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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K120855
Device Name INTELLISPACE ECG
Original Applicant
PHILIPS HEALTHCARE
1525 rancho conejo blvd
suite 100
thousand oaks,  CA  91320
Original Contact gretel lumley
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/21/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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