FDA 510(k) Application Details - K110474

Device Classification Name Monitor, Carbon-Dioxide, Cutaneous

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510(K) Number K110474
Device Name Monitor, Carbon-Dioxide, Cutaneous
Applicant PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN D 71034 DE
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Contact JENS-PETER SEHER
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Regulation Number 868.2480

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Classification Product Code LKD
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Date Received 02/18/2011
Decision Date 09/30/2011
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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