FDA 510(k) Application Details - K020479

Device Classification Name Oximeter

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510(K) Number K020479
Device Name Oximeter
Applicant DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM, MA 02492 US
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Contact JOEL C KENT
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 02/13/2002
Decision Date 03/26/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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