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FDA 510(k) Application Details - K012891
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K012891
Device Name
Oximeter
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON, CA 94588-2719 US
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Contact
RONALD J EHMSEN
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2001
Decision Date
03/07/2002
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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