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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K841868
Device Name MINGOGRAF 7
Applicant
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact JOERGEN ANDERSON
Correspondent
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact JOERGEN ANDERSON
Regulation Number870.2800
Classification Product Code
DSH  
Date Received05/04/1984
Decision Date 10/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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