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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K911990
Device Name ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
Applicant
Somnitec, Inc.
7732 Burnet Ave.
Van Nuys,  CA  91405
Applicant Contact MARK S LONDON
Correspondent
Somnitec, Inc.
7732 Burnet Ave.
Van Nuys,  CA  91405
Correspondent Contact MARK S LONDON
Regulation Number870.2360
Classification Product Code
DRX  
Date Received05/06/1991
Decision Date 06/21/1991
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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