510(k) K894479

30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE by Bennett X-Ray Corp. — Product Code IZO

K894479 is an FDA 510(k) premarket notification submitted by Bennett X-Ray Corp. for the device "30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE". The FDA issued a decision of Substantially Equivalent on September 12, 1989. 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
September 12, 1989
Date Received
July 18, 1989
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