FDA 510(k) Application Details - K041548

Device Classification Name Monitor, Carbon-Dioxide, Cutaneous

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510(K) Number K041548
Device Name Monitor, Carbon-Dioxide, Cutaneous
Applicant SENTEC INC.
S65 W35739 PIPER ROAD
EAGLE, WI 53119 US
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Contact STEPHEN GORSKI
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Regulation Number 868.2480

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Classification Product Code LKD
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Date Received 06/09/2004
Decision Date 08/09/2004
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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