510(k) K933778
K933778 is an FDA 510(k) premarket notification submitted by Whitmore Ent., Inc. for the device "WHITMORE ANKLE X-RAY EXTENSION (AXE)". The FDA issued a decision of Substantially Equivalent on December 13, 1993. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Whitmore Ent., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1993
- Date Received
- August 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type