LCH
9 FDA 510(k) clearances · Product code
37 daysmedian time to decision
111 days90th percentile
9clearances measured
FDA profile
- Official device name
- Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RNA MEDICAL TONOMETER (K922386) | Bionostics, Inc. | 1992-06-26 |
| CLINICAL BLOOD GAS MIXTURES (K904163) | Norco, Inc. | 1990-11-01 |
| BLOOD GAS CALIBRATION STANDARD (K900819) | Cryogenic Rare Gas Laboratories, Inc. | 1990-04-25 |
| AMR RESEARCH TONOMETER (K862958) | Associated Medical Representatives | 1986-11-24 |
| LINEAR CLOUD TONOMETER (K841089) | Linear Tonometers, Inc. | 1984-05-22 |
| HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER (K802379) | American Instrument Co. | 1980-10-31 |
| CORNING 184 BLOOD GAS TONOMETER (K801599) | Corning Medical & Scientific | 1980-08-20 |
| PRECISION GAS MIXER (K781417) | Medicor USA , Ltd. | 1978-09-20 |
| EBS 775 TONOMETER (K781386) | Equilibrated Bio Systems, Inc. | 1978-09-14 |
Track LCH automatically
Every clearance here is in the API, with alerts when new ones post.