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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K901951
Device Name MODEL# MPC
Applicant
Amerisys
1151 Bryn Mawr
Itasca,  IL  60143
Applicant Contact JEFFREY N MOELER
Correspondent
Amerisys
1151 Bryn Mawr
Itasca,  IL  60143
Correspondent Contact JEFFREY N MOELER
Regulation Number892.1700
Classification Product Code
IZO  
Date Received05/01/1990
Decision Date 07/11/1990
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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