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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K950004
Device Name HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
Applicant
Aerotel, Ltd.
5 Hazoref St.
Holon 58856
Israel,  IL
Applicant Contact GEORGE MYERS
Correspondent
Aerotel, Ltd.
5 Hazoref St.
Holon 58856
Israel,  IL
Correspondent Contact GEORGE MYERS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/03/1995
Decision Date 10/24/1995
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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