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FDA 510(k) Application Details - K040581
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K040581
Device Name
Oximeter
Applicant
VITEL NET
8201 GREENSBORO DR.
SUITE 820
MCLEAN, VA 22102 US
Other 510(k) Applications for this Company
Contact
ALLEN IZADPANAH
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
03/04/2004
Decision Date
05/27/2004
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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