KLK · Class II · 21 CFR 868.2500

FDA Product Code KLK: Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Leading manufacturers include Novametrix Medical Systems, Inc., Biochem International, Inc. and Linde Medical Sensors AG.

47
Total
47
Cleared
123d
Avg days
1978
Since

FDA 510(k) Cleared Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Devices (Product Code KLK)

47 devices
1–24 of 47
Cleared May 04, 2001
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K003943
Linde Medical Sensors AG
Anesthesiology · 134d
Cleared May 21, 1999
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K991644
Linde Medical Sensors AG
Anesthesiology · 8d
Cleared Aug 12, 1998
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
K980287
Siemens Medical Solutions USA, Inc.
Anesthesiology · 198d
Cleared Jan 17, 1996
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
K924709
Air-Shields, Inc.
Anesthesiology · 1216d
Cleared Feb 21, 1995
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
K924679
Air-Shields Vickers, Inc.
Anesthesiology · 888d
Cleared Jul 29, 1993
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K925910
Hewlett-Packard Co.
Anesthesiology · 248d
Cleared Jul 14, 1989
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K893133
Mennen Medical, Inc.
Anesthesiology · 80d
Cleared May 27, 1987
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K870805
Novametrix Medical Systems, Inc.
Anesthesiology · 85d
Cleared Jul 10, 1986
515A NEO-TRAK NEONATAL MONITOR
K861861
Ge Medical Systems Information Technologies
Anesthesiology · 57d
Cleared May 09, 1986
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K860124
Mennen Medical, Inc.
Anesthesiology · 115d
Cleared Apr 09, 1986
KONTRON CUTANEOUS PO2 MONITOR 820
K860951
Kontron Instruments, Inc.
Anesthesiology · 28d
Cleared Nov 29, 1985
PO-510 TCPO2 MONITOR
K852959
Sumitomo Electric Industries, Inc.
Anesthesiology · 140d
Cleared Aug 02, 1985
STAT GAS MODULE
K851451
Vulcan Laboratories, Inc.
Anesthesiology · 113d
Cleared Jan 10, 1985
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
K844253
Novametrix Medical Systems, Inc.
Anesthesiology · 69d
Cleared Nov 30, 1984
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
K844079
Novametrix Medical Systems, Inc.
Anesthesiology · 42d
Cleared Oct 04, 1984
SERVOMED OXYMONITO SMK 363
K842497
Litton Datamedix
Anesthesiology · 100d
Cleared Sep 17, 1984
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN
K842374
Novametrix Medical Systems, Inc.
Anesthesiology · 91d
Cleared Apr 24, 1984
TRANSCUTANEOUS 800-OXYGEN MONITORS/801
K840993
Novametrix Medical Systems, Inc.
Anesthesiology · 47d
Cleared Apr 17, 1984
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT
K840918
Biochem International, Inc.
Anesthesiology · 47d
Cleared Apr 17, 1984
DAYPAK SYS VII CATHETER CARE KIT
K840919
Creative Care Systems, Inc.
Anesthesiology · 47d
Cleared Mar 22, 1984
PATIENT MONITOR #404
K831319
Analogic Corp.
Anesthesiology · 335d
Cleared Feb 04, 1984
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
K834057
Instrumentation Laboratory CO
Anesthesiology · 73d
Cleared Dec 22, 1983
OXY MONITOR 5-RANGE DUAL-THERMISTOR
K832652
Litton Medical Electronics
Anesthesiology · 136d
Cleared Nov 29, 1983
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
K830197
Diamond Shamrock Corp.
Anesthesiology · 313d

About Product Code KLK - Regulatory Context