CO-STAT(TM) END TIDAL BREATH ANALYZER
FDA 510(k) clearance K974805 · decided 1998-03-11
Clearance details
- K-number
- K974805
- Device name
- CO-STAT(TM) END TIDAL BREATH ANALYZER
- Applicant
- Natus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-23
- Decision date
- 1998-03-11
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- GHS
- Device class
- 2
- Regulation number
- 864.7425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Carlos, CA, 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 |
|---|---|---|
| ABL520 BLOOD GAS SYSTEM (K910827) | Radiometer America, Inc. | 1991-07-09 |
| TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (K790943) | Corning Medical & Scientific | 1979-06-22 |
| RADIOMHTER OSM-2 HEMOXIMETER (K771263) | The London Co. | 1977-08-03 |
| ECOLYZER CARBOXIMETER (K770209) | Iadec, Inc. | 1977-03-07 |
Recalls involving this device
No recalls on record reference this clearance.