510(k) K950043

JPI AUTOMATIC X-RAY FILM PROCESSOR by Jpi Healthcare Co, Ltd. — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1995
Date Received
January 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type