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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name detector and alarm, arrhythmia
510(k) Number K955023
Device Name BRENTWOOD PC-ECG
Applicant
BRENTWOOD MEDICAL PRODUCTS, INC.
3555 LOMITA BLVD. STE.E
TORRANCE,  CA  90505
Applicant Contact CHANDU PATIL
Correspondent
BRENTWOOD MEDICAL PRODUCTS, INC.
3555 LOMITA BLVD. STE.E
TORRANCE,  CA  90505
Correspondent Contact CHANDU PATIL
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/02/1995
Decision Date 01/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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