FDA 510(k) Application Details - K070260

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K070260
Device Name Detector And Alarm, Arrhythmia
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
M/S 0240
ANDOVER, MA 01810 US
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Contact DENISE HALEY
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 01/26/2007
Decision Date 02/23/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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