510(k) K883431

RAYMAX 2100 MODELS 2130 & 2136 by Raymax Medical Corp. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1988
Date Received
August 15, 1988
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