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FDA 510(k) Application Details - K123797
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K123797
Device Name
Oximeter
Applicant
NEW TECH, INC.
P.O. BOX 237-023
SHANGHAI 200237 CN
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Contact
Diana Hong
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
12/10/2012
Decision Date
08/27/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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