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FDA 510(k) Application Details - K070408
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K070408
Device Name
Oximeter
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON, CA 94588-2719 US
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Contact
JAMES BONDS
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
02/12/2007
Decision Date
05/25/2007
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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