510(k) K925716

BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC by Bennett X-Ray Corp. — Product Code IYB

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