Deployable Oxygen Generation System - Medium (Dogs-M)

FDA 510(k) K071904 · Carleton Life Support Systems, Inc.

Substantially Equivalent

510(k) numberK071904

Submission

Device name
Deployable Oxygen Generation System - Medium (Dogs-M)
Applicant
Carleton Life Support Systems, Inc.
Davenport, IA, US
Received
July 10, 2007
Decision date
October 25, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 Deployable Oxygen Generation System - Medium (Dogs-M) cleared by the FDA?

Deployable Oxygen Generation System - Medium (Dogs-M) (K071904) received a 510(k) decision of Substantially Equivalent on October 25, 2007, 107 days after the submission was received.

What is the product code of K071904?

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