FDA 510(k) Application Details - K120773

Device Classification Name Oximeter

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510(K) Number K120773
Device Name Oximeter
Applicant Covidien LLC
77325 JOYCE WAY
ECHO, OR 97826-. US
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Contact CHARLIE MACK
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 03/14/2012
Decision Date 07/10/2012
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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