510(k) K791959
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1980
- Date Received
- October 1, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Synchronizer, Ecg / Respirator, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1970
- Review Panel
- RA
- Submission Type