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FDA 510(k) Application Details - K083787
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K083787
Device Name
Oximeter
Applicant
SMITHS MEDICAL PM, INC.
N7 W22025 JOHNSON DR.
WAUKESHA, WI 53186-1856 US
Other 510(k) Applications for this Company
Contact
DONALD ALEXANDER
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
12/19/2008
Decision Date
04/15/2009
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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