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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K112692
Device Name IDENTIFY
Applicant
Humediq GmbH
Bahnhofstrabe 108
Grafelfing,  DE 82166
Applicant Contact MORITZ HOYER
Correspondent
Humediq GmbH
Bahnhofstrabe 108
Grafelfing,  DE 82166
Correspondent Contact MORITZ HOYER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/15/2011
Decision Date 08/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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