FDA 510(k) Application Details - K955023

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K955023
Device Name Detector And Alarm, Arrhythmia
Applicant BRENTWOOD MEDICAL PRODUCTS, INC.
3555 LOMITA BLVD. STE.E
TORRANCE, CA 90505 US
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Contact CHANDU PATIL
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 11/02/1995
Decision Date 01/22/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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