FDA 510(k) Application Details - K992238

Device Classification Name Oximeter

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510(K) Number K992238
Device Name Oximeter
Applicant MASIMO CORP.
2852 KELVIN AVE.
IRVINE, CA 92614-5826 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 07/02/1999
Decision Date 10/08/1999
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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