FDA 510(k) Application Details - K062469

Device Classification Name Electrocardiograph

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510(K) Number K062469
Device Name Electrocardiograph
Applicant DEL MAR REYNOLDS MEDICAL, LTD.
377 ROUTE 17 S
HASBROUCK HEIGHTS, NJ 07604 US
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Contact GEORGE MYERS
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 08/24/2006
Decision Date 11/03/2006
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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