LCH · Class I · 21 CFR 862.1660

FDA Product Code LCH: Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical

Leading manufacturers include Equilibrated Bio Systems, Inc., Medicor USA , Ltd. and Corning Medical & Scientific.

9
Total
9
Cleared
52d
Avg days
1978
Since

FDA 510(k) Cleared Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical Devices (Product Code LCH)

9 devices
1–9 of 9
Cleared Jun 26, 1992
RNA MEDICAL TONOMETER
K922386
Bionostics, Inc.
Chemistry · 37d
Cleared Nov 01, 1990
CLINICAL BLOOD GAS MIXTURES
K904163
Norco, Inc.
Chemistry · 51d
Cleared Apr 25, 1990
BLOOD GAS CALIBRATION STANDARD
K900819
Cryogenic Rare Gas Laboratories, Inc.
Chemistry · 63d
Cleared Nov 24, 1986
AMR RESEARCH TONOMETER
K862958
Associated Medical Representatives
Chemistry · 111d
Cleared May 22, 1984
LINEAR CLOUD TONOMETER
K841089
Linear Tonometers, Inc.
Chemistry · 70d
Cleared Oct 31, 1980
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER
K802379
American Instrument Co.
Chemistry · 31d
Cleared Aug 20, 1980
CORNING 184 BLOOD GAS TONOMETER
K801599
Corning Medical & Scientific
Chemistry · 37d
Cleared Sep 20, 1978
PRECISION GAS MIXER
K781417
Medicor USA , Ltd.
Chemistry · 35d
Cleared Sep 14, 1978
EBS 775 TONOMETER
K781386
Equilibrated Bio Systems, Inc.
Chemistry · 34d

About Product Code LCH - Regulatory Context