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FDA 510(k) Application Details - K081870
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K081870
Device Name
Oximeter
Applicant
GE HEALTHCARE FINLAND OY
8200 WEST TOWER AVENUE
MILWAUKEE, WI 53223 US
Other 510(k) Applications for this Company
Contact
JOHN PENDERGAST
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
07/01/2008
Decision Date
07/31/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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