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FDA 510(k) Application Details - K081800
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K081800
Device Name
Oximeter
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE, WI 53224 US
Other 510(k) Applications for this Company
Contact
LAURA SPIEGELHOFF
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
06/25/2008
Decision Date
09/24/2008
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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