Oxlife Freedom Five Oxygen Concentrators, Model KXF5

FDA 510(k) K060922 · Oxlife, LLC

Substantially Equivalent

510(k) numberK060922

Submission

Device name
Oxlife Freedom Five Oxygen Concentrators, Model KXF5
Applicant
Oxlife, LLC
Hendersonville, NC, US
Received
April 4, 2006
Decision date
May 30, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 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 Oxlife Freedom Five Oxygen Concentrators, Model KXF5 cleared by the FDA?

Oxlife Freedom Five Oxygen Concentrators, Model KXF5 (K060922) received a 510(k) decision of Substantially Equivalent on May 30, 2006, 56 days after the submission was received.

What is the product code of K060922?

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