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FDA 510(k) Application Details - K000831
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K000831
Device Name
Oximeter
Applicant
EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10TH ST., SUITE 300
PLANO, TX 75074 US
Other 510(k) Applications for this Company
Contact
KRISTA OAKES
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
03/14/2000
Decision Date
06/05/2000
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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