FDA 510(k) Application Details - K062007

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K062007
Device Name Recorder, Magnetic Tape, Medical
Applicant DIAGNOSTIC MONITORING SOFTWARE
292 KINGSBURY, 32B
P.O. BOX 3109
STATELINE, NV 89449 US
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Contact WILLIAM PARSONS
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 07/17/2006
Decision Date 08/16/2006
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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