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., Ge Medical Systems Information Technologies and Mennen Medical, Inc..

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 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 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 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 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 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 Jul 19, 1983
TRANSCUTANEOUS OXYGEN MONITOR OPTION
K831744
Ge Medical Systems Information Technologies
Anesthesiology · 49d
Cleared Sep 07, 1982
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
K822328
Instrumentation Laboratory CO
Anesthesiology · 35d
Cleared Aug 16, 1982
CRITIKON OXYGEN MONITOR, MODEL 8030
K821936
Critikon Company, LLC
Anesthesiology · 48d
Cleared Feb 12, 1982
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
K813350
Novametrix Medical Systems, Inc.
Anesthesiology · 77d
Cleared Jan 26, 1982
CRITIKON TRANSCUTANEOUS GAS MONITORS
K813347
Critikon Company, LLC
Anesthesiology · 60d
Cleared Jan 07, 1982
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
K813352
Novametrix Medical Systems, Inc.
Anesthesiology · 41d
Cleared Dec 31, 1981
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER
K813351
Novametrix Medical Systems, Inc.
Anesthesiology · 34d
Cleared Aug 31, 1981
MODEL 78850 OXYGEN MONITOR
K812167
Hewlett-Packard Co.
Anesthesiology · 32d
Cleared Jun 24, 1981
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K810999
Cordis Corp.
Anesthesiology · 72d
Cleared May 28, 1980
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR
K800988
Novametrix Medical Systems, Inc.
Anesthesiology · 34d

About Product Code KLK - Regulatory Context