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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827993
Device Name MTH C/A MOBILE C ARM
Applicant
General Medical Merate S.P.A
Via Partgiani, 25
Seriate, Bergamo,  IT 24068
Correspondent
General Medical Merate S.P.A
Via Partgiani, 25
Seriate, Bergamo,  IT 24068
Date Received08/24/1982
Decision Date 09/13/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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