510(k) K925716
K925716 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC". The FDA issued a decision of Substantially Equivalent on December 17, 1992. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1992
- Date Received
- November 12, 1992
- 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