Panels › Clinical Chemistry › Product code LCH · Class 1
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Regulation 862.1660
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LCH
| Company | 510(k)s | Recalls |
|---|---|---|
| EMD Chemicals Inc | 0 | 2 |
| American Instrument Co. | 1 | 0 |
| Associated Medical Representatives | 1 | 0 |
| Bionostics, Inc. | 1 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Cryogenic Rare Gas Laboratories, Inc. | 1 | 0 |
| Equilibrated Bio Systems, Inc. | 1 | 0 |
| Linear Tonometers, Inc. | 1 | 0 |
| Medicor USA , Ltd. | 1 | 0 |
| Norco, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 1992 | K922386 | RNA MEDICAL TONOMETER Bionostics, Inc. | LCH |
| Nov 1, 1990 | K904163 | CLINICAL BLOOD GAS MIXTURES Norco, Inc. | LCH |
| Apr 25, 1990 | K900819 | BLOOD GAS CALIBRATION STANDARD Cryogenic Rare Gas Laboratories, Inc. | LCH |
| Nov 24, 1986 | K862958 | AMR RESEARCH TONOMETER Associated Medical Representatives | LCH |
| May 22, 1984 | K841089 | LINEAR CLOUD TONOMETER Linear Tonometers, Inc. | LCH |
| Oct 31, 1980 | K802379 | HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER American Instrument Co. | LCH |
| Aug 20, 1980 | K801599 | CORNING 184 BLOOD GAS TONOMETER Corning Medical & Scientific | LCH |
| Sep 20, 1978 | K781417 | PRECISION GAS MIXER Medicor USA , Ltd. | LCH |
| Sep 14, 1978 | K781386 | EBS 775 TONOMETER Equilibrated Bio Systems, Inc. | LCH |
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