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FDA 510(k) Application Details - K121167
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K121167
Device Name
Generator, Oxygen, Portable
Applicant
CAIRE INC.
2200 AIRPORT INDUSTRIAL DRIVE
SUITE 500
BALL GROUND, GA 30107 US
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Contact
BEN KADRLIK
Other 510(k) Applications for this Contact
Regulation Number
868.5440
More FDA Info for this Regulation Number
Classification Product Code
CAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2012
Decision Date
05/02/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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