FDA 510(k) Application Details - K033078

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K033078
Device Name System,Network And Communication,Physiological Monitors
Applicant DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM, MA 02492 US
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Contact JOEL KENT
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 09/29/2003
Decision Date 10/29/2003
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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