510(k) K883092

BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR by Bennett X-Ray Corp. — Product Code IZL

K883092 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1988
Date Received
July 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type