CO-STAT(TM) END TIDAL BREATH ANALYZER— 510(k) K974805
Substantially EquivalentNatus Medical, Inc.
FDA 510(k) clearance K974805 for CO-STAT(TM) END TIDAL BREATH ANALYZER, Substantially Equivalent on 1998-03-11. Applicant: Natus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Natus Medical, Inc.
- Product code
- Code GHS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Carlos, CA, US
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