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FDA 510(k) Application Details - K043003
Device Classification Name
Monitor, Carbon-Dioxide, Cutaneous
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510(K) Number
K043003
Device Name
Monitor, Carbon-Dioxide, Cutaneous
Applicant
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ DK-2700 DK
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Contact
PIERRE PELLETIER
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Regulation Number
868.2480
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Classification Product Code
LKD
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Date Received
11/01/2004
Decision Date
03/01/2005
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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