FDA 510(k) Application Details - K962603

Device Classification Name Oximeter

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510(K) Number K962603
Device Name Oximeter
Applicant MASIMO CORP.
23361 MADERO ST.
SUITE 100
MISSION VIEJO, CA 92691 US
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Contact JAMES J CRONIN
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 07/02/1996
Decision Date 02/06/1997
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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