Lifechoice Oxygen Concentrator, Model OXY1000

FDA 510(k) K072688 · International Biophysics Corp.

Substantially Equivalent

510(k) numberK072688

Submission

Device name
Lifechoice Oxygen Concentrator, Model OXY1000
Applicant
International Biophysics Corp.
Austin, TX, US
Received
September 24, 2007
Decision date
January 11, 2008
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAW – Generator, Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5440
Specialty
Anesthesiology

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Questions and answers

When was Lifechoice Oxygen Concentrator, Model OXY1000 cleared by the FDA?

Lifechoice Oxygen Concentrator, Model OXY1000 (K072688) received a 510(k) decision of Substantially Equivalent on January 11, 2008, 109 days after the submission was received.

What is the product code of K072688?

The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.