ClearanceBrief
510(k) K030407 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

ADVISOR, MODEL 9200

ApplicantBci, Inc., Waukesha WI, US
DecisionSubstantially Equivalent, Aug 19, 2003
ReceivedFeb 7, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K030407

DateFirm and productCodeLinked 510(k)
Nov 29, 2017Smiths Medical ASD Inc.
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installe
Terminated
CCKNone listed
May 29, 2015Smiths Medical ASD, Inc.
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
Terminated
CCKNone listed
Mar 2, 2010Smiths Medical PM, Inc.
9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).
Terminated
CCKNone listed
May 15, 2009Smiths Medical PM, Inc.
Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 9254743
Terminated
CCKNone listed
Jul 23, 2007Smiths Medical PM, Inc.
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
Terminated
MWINone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
Nov 30, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325.
Terminated
DPSNone listed
May 12, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325.
Terminated
DPSNone listed
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio
Terminated
DPSNone listed
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654220. item Description 9200 II 3LD/RSP/SP02 MDD MEDEXL. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio
Terminated
DPSNone listed
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200 II 3LD/RP/O2/IP/TP/BATT ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio
Terminated
DPSNone listed
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration
Terminated
DPSNone listed
Feb 10, 2005Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration
Terminated
DPSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.