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FDA 510(k) Application Details - K131253
Device Classification Name
Monitor, Carbon-Dioxide, Cutaneous
More FDA Info for this Device
510(K) Number
K131253
Device Name
Monitor, Carbon-Dioxide, Cutaneous
Applicant
PERIMED AB
DATAVAGEN 9 A
JARFALLA 17543 SE
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Contact
MARIA LILJEVRET
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Regulation Number
868.2480
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Classification Product Code
LKD
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More FDA Info for this Product Code
Date Received
05/02/2013
Decision Date
10/22/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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