510(k) K851011

HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR by Hofmann X-Ray of America, Inc. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
March 12, 1985
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