FDA 510(k) Application Details - K040945

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K040945
Device Name System,Network And Communication,Physiological Monitors
Applicant Draeger Medical Systems, Inc.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact PENELOPE H GRECO
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 04/12/2004
Decision Date 05/12/2004
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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