510(k) K974805
- Device
- CO-STAT(TM) END TIDAL BREATH ANALYZER
- Applicant
- NATUS MEDICAL, INC.
- 510(k) number
- K974805
- Product code
- GHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-03-11
- Date received
- 1997-12-23
- Regulation
- 864.7425
- Classification name
- Assay, Carboxyhemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ESTHER KADASH
- Address
- 1501 Industrial Rd. San Carlos CA US 94070 94070
FDA Registration Numbers#
- 3014506106
- 1220649
- 3037000637
- 3023162659
- 3002807968
- 2431530
- 3007490412
- 9610126
- 3013513377
- 3006198300
- 3003795116
- 1219029
- 1217183
Source Documents#
Other 510(k) Records For Product Code GHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910827 | ABL520 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1991-07-09 |
| K790943 | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | Corning Medical & Scientific | 1979-06-22 |
| K771263 | RADIOMHTER OSM-2 HEMOXIMETER | The London Co. | 1977-08-03 |
| K770209 | ECOLYZER CARBOXIMETER | Iadec, Inc. | 1977-03-07 |
Legacy Summary#
summary
FDA Review#
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