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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 K973735
Device Name MICROVIT MT-100
Applicant
Schiller America, Inc.
3002 Dow Ave., #138
Tustin,  CA  92780
Applicant Contact MARKUS MARITZ
Correspondent
Schiller America, Inc.
3002 Dow Ave., #138
Tustin,  CA  92780
Correspondent Contact MARKUS MARITZ
Regulation Number870.2800
Classification Product Code
DSH  
Date Received09/30/1997
Decision Date 08/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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