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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 K920572
Device Name UNISCAN 24 ECG ROCORDER
Applicant
Uniscan , Ltd.
1564 Calle Orinda
Camarillo,  CA  93010
Applicant Contact JOHN A HUMPHREY
Correspondent
Uniscan , Ltd.
1564 Calle Orinda
Camarillo,  CA  93010
Correspondent Contact JOHN A HUMPHREY
Regulation Number870.2800
Classification Product Code
DSH  
Date Received02/07/1992
Decision Date 04/06/1992
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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