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FDA 510(k) Application Details - K010718
Device Classification Name
Oximeter, Ear
More FDA Info for this Device
510(K) Number
K010718
Device Name
Oximeter, Ear
Applicant
EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10TH ST., SUITE 300
PLANO, TX 75074 US
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Contact
KRISTA OAKES
Other 510(k) Applications for this Contact
Regulation Number
870.2710
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Classification Product Code
DPZ
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More FDA Info for this Product Code
Date Received
03/12/2001
Decision Date
03/23/2001
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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