FDA 510(k) Application Details - K021453

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K021453
Device Name Automated External Defibrillators (Non-Wearable)
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact RICHARD J PETERSEN
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 05/06/2002
Decision Date 07/03/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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