Lifechoice Oxygen Concentrator

FDA 510(k) K113317 · Inova Labs, Inc.

Substantially Equivalent

510(k) numberK113317

Submission

Device name
Lifechoice Oxygen Concentrator
Applicant
Inova Labs, Inc.
Austin, TX, US
Received
November 10, 2011
Decision date
December 28, 2011
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 Lifechoice Oxygen Concentrator cleared by the FDA?

Lifechoice Oxygen Concentrator (K113317) received a 510(k) decision of Substantially Equivalent on December 28, 2011, 48 days after the submission was received.

What is the product code of K113317?

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