510(k) K812613
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1981
- Date Received
- September 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, X-Ray, Fluorographic, Cine Or Spot
- Device Class
- Class II
- Regulation Number
- 892.1620
- Review Panel
- RA
- Submission Type