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FDA 510(k) Application Details - K173238
Device Classification Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K173238
Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant
Bedfont Scientific Ltd
Station Road, Harrietsham
Maidstone ME17 1JA GB
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Contact
Louise Bateman
Other 510(k) Applications for this Contact
Regulation Number
868.1430
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Classification Product Code
CCJ
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More FDA Info for this Product Code
Date Received
10/05/2017
Decision Date
04/04/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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