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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 K942862
Device Name HEARTPRINT
Applicant
Medata, Inc.
P.O. Box 2112,
Thousand Oaks,  CA  91358
Applicant Contact JOHN A HUMPHREY
Correspondent
Medata, Inc.
P.O. Box 2112,
Thousand Oaks,  CA  91358
Correspondent Contact JOHN A HUMPHREY
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/17/1994
Decision Date 01/18/1995
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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