510(k) K780185
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1978
- Date Received
- February 6, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- Device Class
- Class II
- Regulation Number
- 868.1150
- Review Panel
- AN
- Submission Type