510(k) K780128
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1978
- Date Received
- January 24, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type