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FDA 510(k) Application Details - K033715
Device Classification Name
Oximeter
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510(K) Number
K033715
Device Name
Oximeter
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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DAVID OSBORN
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
DQA
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More FDA Info for this Product Code
Date Received
11/26/2003
Decision Date
02/13/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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