FDA 510(k) Application Details - K982025

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K982025
Device Name Automated External Defibrillators (Non-Wearable)
Applicant HEWLETT-PACKARD CO.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1085 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 06/09/1998
Decision Date 09/04/1998
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
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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