Lifechoice Oxygen Concentrator, Model OXY1000
FDA 510(k) K072688 · International Biophysics Corp.
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
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.