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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K030323
Device Name MRI-CADDY
Applicant
Mammendorfer Institute For Physics & Medicine GmbH
13605 W. 7th Ave.
Golden,  CO  80401
Applicant Contact ROBERT N CLARK
Correspondent
Mammendorfer Institute For Physics & Medicine GmbH
13605 W. 7th Ave.
Golden,  CO  80401
Correspondent Contact ROBERT N CLARK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/30/2003
Decision Date 04/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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