FDA 510(k) Application Details - K201179

Device Classification Name Oximeter

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510(K) Number K201179
Device Name Oximeter
Applicant Covidien llc
6135 Gunbarrel Avenue
Boulder, CO 80301 US
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Contact Ligia Mastronardi
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 05/01/2020
Decision Date 07/20/2020
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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