ClearanceBrief
Panels › Anesthesiology › Product code CCK · Class 2

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Regulation 868.1400

3510(k)s in 12 months (307 all time)
0recalls in 12 months (98 all time)
89recalls that name a 510(k)
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Top companies in CCK

DateFirm and productCodeLinked 510(k)
May 25, 2011Oridion Medical 1987 Ltd.
Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine a
Terminated
CCKNone listed
May 25, 2011Oridion Medical 1987 Ltd.
MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO 25UN DRAEGER(Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine a
Terminated
CCKNone listed
May 25, 2011Oridion Medical 1987 Ltd.
MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and Vit
Terminated
CCKNone listed
May 25, 2011Oridion Medical 1987 Ltd.
MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine
Terminated
CCKNone listed
May 23, 2011Salter Laboratories, Division of Regulatory Affairs
Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respi
Terminated
CCKNone listed
May 20, 2011Salter Laboratories, Division of Regulatory Affairs
Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula. Single Patien
Terminated
CCKK892406
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream O2/CO2 NASAL FILTERLINE ADULT LONG O2 CONN 100UN Part Number: 010343 010341 Part Number: 10341
Terminated
CCKK011024
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number: 10341
Terminated
CCKK011536
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream FILTERLINE SET ADU/PED 25UN Part Number: XS04620-01 Oridion XS04661 Physio Control
Terminated
CCKK980324
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream FILTERLINE H SET ADULT/PEDIATRIC 100 UN Part Number: 010580-01
Terminated
CCKK980327
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream FILTERLINE SET ADULT/PEDIATRIC 100 UN Part Number: 010579-01
Terminated
CCKK980324
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625
Terminated
CCKK011536
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE H PLUS O2 ADU/INT 25UN Part Number: 010433
Terminated
CCKK011536
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 100UN Part Number: 010210 Oridion 3012176-112 Physio Control
Terminated
CCKK011536
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS 100 UN Part Number: 010209 Oridion 3012176-111 Physio Control
Terminated
CCKK011050
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN Part Number: 009826
Terminated
CCKK011536
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control
Terminated
CCKK011536
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion 3012176-011 Physio Control
Terminated
CCKK011050
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream CAPNOLINE H O2 ADULT 25UN Part Number: 008180
Terminated
CCKK010024
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream CAPNOLINE H ADULT 25UN Part Number: 008177
Terminated
CCKK980325
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream NIVLINE ADULT 25UN Part Number: 008174
Terminated
CCKK980325
Jul 13, 2010Oridion Medical 1987 Ltd.
Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN Part Number: 006912
Terminated
CCKK010024
Apr 8, 2010Philips Healthcare Inc.
Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the
Terminated
CCKK963327
Apr 8, 2010Philips Healthcare Inc.
100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechan
Terminated
CCKK030886
Apr 8, 2010Philips Healthcare Inc.
Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the i
Terminated
CCKK963327
Apr 8, 2010Philips Healthcare Inc.
100-120V Capnogard 1265, Refurbished, Respironics/Philips product. Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments in ventilatory support
Terminated
CCKK910019
Apr 8, 2010Philips Healthcare Inc.
NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during ge
Terminated
CCKK030886
Apr 8, 2010Philips Healthcare Inc.
NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during gene
Terminated
CCKK030886
Apr 8, 2010Philips Healthcare Inc.
Tidal Wave Model 615, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensiv
Terminated
CCKK963327
Apr 8, 2010Philips Healthcare Inc.
Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during gene
Terminated
CCKK030886
Apr 8, 2010Philips Healthcare Inc.
French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during gene
Terminated
CCKK030886
Apr 8, 2010Philips Healthcare Inc.
100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation
Terminated
CCKK030886
Apr 8, 2010Philips Healthcare Inc.
Tidal wave, Model 610, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensi
Terminated
CCKK963327
Apr 8, 2010Philips Healthcare Inc.
Spanish Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments.
Terminated
CCKK910019
Apr 8, 2010Philips Healthcare Inc.
100-120V Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring end tidal CO2 and respiration rate in all critical monitoring environments.
Terminated
CCKK910019
Apr 8, 2010Philips Healthcare Inc.
Evaluation Kit, LOFLO Engine, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring.
Terminated
CCKK053174
Apr 8, 2010Philips Healthcare Inc.
C5 LOFLO Evaluation Kit, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring.
Terminated
CCKK053174
Apr 8, 2010Philips Healthcare Inc.
NICO2, Model 7600 Respironics/Philips Product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation.
Terminated
CCKK030886
Apr 8, 2010Philips Healthcare Inc.
Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system.
Terminated
CCKK042601
Mar 2, 2010Smiths Medical PM, Inc.
8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330.
Terminated
CCKK991086
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
CCKK030407
Sep 21, 2009Oridion Medical 1987 Ltd.
Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
Terminated
CCKK060065
Sep 8, 2009Covidien Limited
Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). Intended for u
Terminated
CCKK944400
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
CCKK010770
K011177 +2
Sep 29, 2006Respironics Novametrix, LLC.
NICO Model 7300 Cardiopulmonary Management System
Terminated
CCKK030886
K041450 +1
Feb 16, 2006Spacelabs Medical Incorporated
Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ven
Terminated
CCKK031124
Sep 2, 2004Nellcor Puritan Bennett
The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each pr
Terminated
CCKK010795
Jan 31, 2004Nihon Kohden America Inc
AG-920RA Multi-gas unit analyzer
Terminated
CCKNone listed

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