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510(k) K960309

AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) by Airsep Corp. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1997
Date Received
January 5, 1996
Clearance Type
Traditional
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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