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510(k) K120785

OMNI 3 OXYGEN SYSTEM by Caire, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2012
Date Received
March 15, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

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