510(k) K914944
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1991
- Date Received
- November 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Mount, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1770
- Review Panel
- RA
- Submission Type