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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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More FDA Info for this Product Code
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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