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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K955706
Device Name JPI AUTOMATIC X-RAY FILM PROCESSOR
Applicant
Jpi Healthcare Co, Ltd.
41-02 Bell Blvd.
Suite Ll3
Bayside,  NY  11361
Applicant Contact KIM M LEE
Correspondent
Jpi Healthcare Co, Ltd.
41-02 Bell Blvd.
Suite Ll3
Bayside,  NY  11361
Correspondent Contact KIM M LEE
Regulation Number892.1900
Classification Product Code
IXW  
Date Received12/15/1995
Decision Date 02/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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