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FDA 510(k) Application Details - K070193
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K070193
Device Name
Oximeter
Applicant
ENVITEC-WISMAR GMBH
S65 W35739 PIPER ROAD
EAGLE, WI 53119 US
Other 510(k) Applications for this Company
Contact
STEPHEN GORSKI
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
01/22/2007
Decision Date
05/02/2007
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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