FDA 510(k) Application Details - K131253

Device Classification Name Monitor, Carbon-Dioxide, Cutaneous

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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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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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