FDA 510(k) Application Details - K141542

Device Classification Name Oximeter

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510(K) Number K141542
Device Name Oximeter
Applicant Covidien LLC
6135 Gunbarrel Ave
BOULDER, CO 80301 US
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Contact MIA M WARE
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 06/10/2014
Decision Date 10/02/2014
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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