FDA 510(k) Application Details - K823586

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K823586
Device Name Detector And Alarm, Arrhythmia
Applicant BRENTWOOD INSTRUMENTS, INC.

, US
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 12/06/1982
Decision Date 04/06/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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