Panels › Anesthesiology › Product code KLK · Class 2
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation 868.2500
0510(k)s in 12 months (47 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in KLK
| Company | 510(k)s | Recalls |
|---|---|---|
| Novametrix Medical Systems, Inc. | 13 | 0 |
| Biochem International, Inc. | 3 | 0 |
| Radiometer America Inc | 0 | 3 |
| Critikon Company, LLC | 2 | 0 |
| Ge Medical Systems Information Technologies | 2 | 0 |
| Hewlett-Packard Co. | 2 | 0 |
| Instrumentation Laboratory CO | 2 | 0 |
| Linde Medical Sensors AG | 2 | 0 |
| Mennen Medical, Inc. | 2 | 0 |
| Sumitomo Electric Industries, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2001 | K003943 | MICROGAS 7650 TRANSCUTANEOUS MONITOR Linde Medical Sensors AG, CH | KLK |
| May 21, 1999 | K991644 | MICROGAS 7650 TRANSCUTANEOUS MONITOR Linde Medical Sensors AG, CH | KLK |
| Aug 12, 1998 | K980287 | SIEMENS SC9000/SC9015 TCP02/C02 MODULE Siemens Medical Solutions USA, Inc. | KLK |
| Jan 17, 1996 | K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE Air-Shields, Inc. | KLK |
| Feb 21, 1995 | K924679 | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR Air-Shields Vickers, Inc. | KLK |
| Jul 29, 1993 | K925910 | HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE Hewlett-Packard Co., DE | KLK |
| Jul 14, 1989 | K893133 | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX Mennen Medical, Inc. | KLK |
| May 27, 1987 | K870805 | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR Novametrix Medical Systems, Inc. | KLK |
| Jul 10, 1986 | K861861 | 515A NEO-TRAK NEONATAL MONITOR Ge Medical Systems Information Technologies | KLK |
| May 9, 1986 | K860124 | HORIZON 2000 TRANSCUTANEOUS GAS MONITORING Mennen Medical, Inc. | KLK |
| Apr 9, 1986 | K860951 | KONTRON CUTANEOUS PO2 MONITOR 820 Kontron Instruments, Inc. | KLK |
| Nov 29, 1985 | K852959 | PO-510 TCPO2 MONITOR Sumitomo Electric Industries, Inc., JP | KLK |
| Aug 2, 1985 | K851451 | STAT GAS MODULE Vulcan Laboratories, Inc. | KLK |
| Jan 10, 1985 | K844253 | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 Novametrix Medical Systems, Inc. | KLK |
| Nov 30, 1984 | K844079 | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN Novametrix Medical Systems, Inc. | KLK |
| Oct 4, 1984 | K842497 | SERVOMED OXYMONITO SMK 363 Litton Datamedix | KLK |
| Sep 17, 1984 | K842374 | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN Novametrix Medical Systems, Inc. | KLK |
| Apr 24, 1984 | K840993 | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 Novametrix Medical Systems, Inc. | KLK |
| Apr 17, 1984 | K840919 | DAYPAK SYS VII CATHETER CARE KIT Creative Care Systems, Inc. | KLK |
| Apr 17, 1984 | K840918 | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT Biochem International, Inc. | KLK |
| Mar 22, 1984 | K831319 | PATIENT MONITOR #404 Analogic Corp. | KLK |
| Feb 4, 1984 | K834057 | IL 301 PORTABLE TRANSCUT. OXYGEN MONI Instrumentation Laboratory CO | KLK |
| Dec 22, 1983 | K832652 | OXY MONITOR 5-RANGE DUAL-THERMISTOR Litton Medical Electronics | KLK |
| Nov 29, 1983 | K830197 | TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS Diamond Shamrock Corp. | KLK |
| Jul 19, 1983 | K831744 | TRANSCUTANEOUS OXYGEN MONITOR OPTION Ge Medical Systems Information Technologies | KLK |
| Jul 12, 1983 | K831460 | AS 30/TCP MODULE Narco Scientific | KLK |
| Sep 7, 1982 | K822328 | IL 301 TRANSCUTANEOUS OXYGEN MONITOR Instrumentation Laboratory CO | KLK |
| Aug 16, 1982 | K821936 | CRITIKON OXYGEN MONITOR, MODEL 8030 Critikon Company, LLC | KLK |
| Feb 12, 1982 | K813350 | NOVAMETRIX MODEL 807 TRANSCUT. MONITOR Novametrix Medical Systems, Inc. | KLK |
| Jan 26, 1982 | K813347 | CRITIKON TRANSCUTANEOUS GAS MONITORS Critikon Company, LLC | KLK |
| Jan 7, 1982 | K813352 | NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN Novametrix Medical Systems, Inc. | KLK |
| Dec 31, 1981 | K813351 | NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER Novametrix Medical Systems, Inc. | KLK |
| Aug 31, 1981 | K812167 | MODEL 78850 OXYGEN MONITOR Hewlett-Packard Co. | KLK |
| Jul 27, 1981 | K811836 | PO-200 BLOOD OXYGEN MONITOR Sumitomo Electric Industries, Inc. | KLK |
| Jun 24, 1981 | K810999 | CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS Cordis Corp. | KLK |
| Jun 12, 1981 | K811470 | LIFESPAN 100 Biochem International, Inc. | KLK |
| Feb 2, 1981 | K802978 | TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 Brattle Instrument Corp. | KLK |
| Dec 17, 1980 | K802846 | TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. The London Co. | KLK |
| May 28, 1980 | K800988 | NOVAMETRIX TCOMETTE #809 TRANS. MONITOR Novametrix Medical Systems, Inc. | KLK |
| Apr 2, 1980 | K800631 | OXYMETER Dragerwerk AG | KLK |
| Nov 21, 1979 | K791559 | ROCHE SENSOR ADAPTOR Roche Medical Electronics, Inc. | KLK |
| Nov 16, 1979 | K792011 | TC02M PRECISION GAS CALIBRATOR Novametrix Medical Systems, Inc. | KLK |
| Oct 26, 1979 | K792010 | TC02M ELECTRODE ADHESIVE RINGS Novametrix Medical Systems, Inc. | KLK |
| Oct 26, 1979 | K792009 | TC02 M OXYGEN ELECTRODE CONTACT Novametrix Medical Systems, Inc. | KLK |
| Aug 3, 1979 | K791152 | TCO2M MODEL 818 Novametrix Medical Systems, Inc. | KLK |
| Dec 26, 1978 | K781910 | MONITOR, SENSOMATIII OXYGEN Biochem International, Inc. | KLK |
| Oct 10, 1978 | K780458 | TRANSCUTANEOUS OXYGEN PERFUSION MONITOR Narco Air-Shields | KLK |
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