510(k) K982279 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
| Applicant | Bci Intl., Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 25, 1998 |
| Received | Jun 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982279
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2009 | Smiths 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 |
CCK | None listed |
| Jul 23, 2007 | Smiths Medical PM, Inc. BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200) Terminated |
MWI | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| Nov 30, 2005 | Smiths 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 |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325. Terminated |
DPS | None listed |
| May 12, 2005 | Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325. Terminated |
DPS | None listed |
| Feb 10, 2005 | Smiths 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 |
DPS | None listed |
| Feb 10, 2005 | Smiths 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 |
DPS | None listed |
| Feb 10, 2005 | Smiths 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 |
DPS | None listed |
| Feb 10, 2005 | Smiths 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 |
DPS | None listed |
| Feb 10, 2005 | Smiths 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 |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.