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FDA 510(k) Application Details - K110474
Device Classification Name
Monitor, Carbon-Dioxide, Cutaneous
More FDA Info for this Device
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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More FDA Info for this Product Code
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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