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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 K050896
Device Name H12+ HOLTER RECORDER
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
milwaukee,  WI  53224
Applicant Contact harlan l van matre
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
milwaukee,  WI  53224
Correspondent Contact harlan l van matre
Regulation Number870.2800
Classification Product Code
DSH  
Date Received04/08/2005
Decision Date 08/24/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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