510(k) K905827
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1991
- Date Received
- December 31, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Scintillation (Gamma)
- Device Class
- Class I
- Regulation Number
- 892.1100
- Review Panel
- RA
- Submission Type