FDA 510(k) Application Details - K032949

Device Classification Name Oximeter

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510(K) Number K032949
Device Name Oximeter
Applicant RESPIRONICS NOVAMETRIX, INC.
5 TECHNOLOGY DR.
WALLINGFORD, CT 06492 US
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Contact MICHAEL J MALIS
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 09/22/2003
Decision Date 08/23/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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