510(k) K912696

TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL by Bennett X-Ray Corp. — Product Code IYB

K912696 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL". The FDA issued a decision of Substantially Equivalent on September 16, 1991. 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
September 16, 1991
Date Received
June 18, 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