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FDA 510(k) Application Details - K021955
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K021955
Device Name
Oximeter
Applicant
DATEX-OHMEDA, INC.
1315 WEST CENTURY DR.
LOUISVILLE, CO 80027 US
Other 510(k) Applications for this Company
Contact
MICHAEL A CHILBERT
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
06/14/2002
Decision Date
10/08/2002
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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