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FDA 510(k) Application Details - K052377
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K052377
Device Name
Oximeter
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
HEWLETT-PACKARD STR.2
BOEBLINGEN D 71034 DE
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Contact
EGON PFEIL
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2005
Decision Date
11/17/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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