510(k) K935068

RADIOGRAPHIC GENERATOR HFQ-WHIS by Bennett X-Ray Corp. — Product Code IZO

K935068 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "RADIOGRAPHIC GENERATOR HFQ-WHIS". The FDA issued a decision of Substantially Equivalent on December 13, 1993. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Bennett X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1993
Date Received
October 25, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type