FDA 510(k) Application Details - K171408

Device Classification Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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510(K) Number K171408
Device Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant Carrot Sense, Inc.
1600 Seaport Blvd, Suite 150
Redwood City, CA 94063 US
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Contact Daniel J. Balbierz
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Regulation Number 868.1430

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Classification Product Code CCJ
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Date Received 05/12/2017
Decision Date 09/29/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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