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 Mennen Medical, Inc..

47
Total
47
Cleared
123d
Avg days
1978
Since
47 devices
25–47 of 47
Cleared Jul 19, 1983
TRANSCUTANEOUS OXYGEN MONITOR OPTION
K831744
Ge Medical Systems Information Technologies
Anesthesiology · 49d
Cleared Jul 12, 1983
AS 30/TCP MODULE
K831460
Narco Scientific
Anesthesiology · 67d
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 Jul 27, 1981
PO-200 BLOOD OXYGEN MONITOR
K811836
Sumitomo Electric Industries, Inc.
Anesthesiology · 27d
Cleared Jun 24, 1981
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K810999
Cordis Corp.
Anesthesiology · 72d
Cleared Jun 12, 1981
LIFESPAN 100
K811470
Biochem International, Inc.
Anesthesiology · 17d
Cleared Feb 02, 1981
TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
K802978
Brattle Instrument Corp.
Anesthesiology · 73d
Cleared Dec 17, 1980
TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.
K802846
The London Co.
Anesthesiology · 35d
Cleared May 28, 1980
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR
K800988
Novametrix Medical Systems, Inc.
Anesthesiology · 34d
Cleared Apr 02, 1980
OXYMETER
K800631
Dragerwerk AG
Anesthesiology · 13d
Cleared Nov 21, 1979
ROCHE SENSOR ADAPTOR
K791559
Roche Medical Electronics, Inc.
Anesthesiology · 96d
Cleared Nov 16, 1979
TC02M PRECISION GAS CALIBRATOR
K792011
Novametrix Medical Systems, Inc.
Anesthesiology · 42d
Cleared Oct 26, 1979
TC02 M OXYGEN ELECTRODE CONTACT
K792009
Novametrix Medical Systems, Inc.
Anesthesiology · 21d
Cleared Oct 26, 1979
TC02M ELECTRODE ADHESIVE RINGS
K792010
Novametrix Medical Systems, Inc.
Anesthesiology · 21d
Cleared Aug 03, 1979
TCO2M MODEL 818
K791152
Novametrix Medical Systems, Inc.
Anesthesiology · 45d
Cleared Dec 26, 1978
MONITOR, SENSOMATIII OXYGEN
K781910
Biochem International, Inc.
Anesthesiology · 42d
Cleared Oct 10, 1978
TRANSCUTANEOUS OXYGEN PERFUSION MONITOR
K780458
Narco Air-Shields
Anesthesiology · 201d