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510(k) K072688

LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 by International Biophysics Corp. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2008
Date Received
September 24, 2007
Clearance Type
Abbreviated
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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  • K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) (May 14, 1996)
  • K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) (May 14, 1996)

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