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FDA 510(k) Application Details - K151329
Device Classification Name
Monitor, Carbon-Dioxide, Cutaneous
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510(K) Number
K151329
Device Name
Monitor, Carbon-Dioxide, Cutaneous
Applicant
SENTEC AG
RINGSTRASSE 39
THERWIL 4106 CH
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Contact
ANKE WEISBRICH
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Regulation Number
868.2480
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Classification Product Code
LKD
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Date Received
05/18/2015
Decision Date
12/17/2015
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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