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FDA 510(k) Application Details - K113865
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K113865
Device Name
Oximeter
Applicant
SHARP CORPORATION
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON, TX 75080 US
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Contact
DIANE RUTHERFORD
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
DQA
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More FDA Info for this Product Code
Date Received
12/30/2011
Decision Date
03/21/2012
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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