CORNING 184 BLOOD GAS TONOMETER
FDA 510(k) clearance K801599 · decided 1980-08-20
Clearance details
- K-number
- K801599
- Device name
- CORNING 184 BLOOD GAS TONOMETER
- Applicant
- Corning Medical & Scientific
- Decision
- Substantially Equivalent
- Date received
- 1980-07-14
- Decision date
- 1980-08-20
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- LCH
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| PRECISION GAS MIXER (K781417) | Medicor USA , Ltd. | 1978-09-20 |
| EBS 775 TONOMETER (K781386) | Equilibrated Bio Systems, Inc. | 1978-09-14 |
Recalls involving this device
No recalls on record reference this clearance.