Total O2

FDA 510(k) K013472 · Chad Therapeutics, Inc.

Substantially Equivalent

510(k) numberK013472

Submission

Device name
Total O2
Applicant
Chad Therapeutics, Inc.
Chatsworth, CA, US
Received
October 18, 2001
Decision date
November 28, 2001
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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More from Devilbiss Healthcare, LLC

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K033364Chad Therapeutics SageNFB · Traditional 05/11/2004SE
K020475Chad Therapeutics Oxypenumatic Cypress Model 511NFB · Traditional 07/05/2002SE
K010389Chad Therapeutics Oxymatic Model 401 and Oxymatic Model 411NFB · Special 03/23/2001SE
K003455Modification to Chad Therapeutics Oxymatic Model 401NFB · Special 12/06/2000SE
K000890Chad Therapeutics Oxymatic Model 401NFB · Traditional 06/16/2000SE
K971889Chad Total O2 Delivery SystemCAW · Traditional 11/17/1997SE
K884562OXYMATIC-24NFB · Traditional 01/09/1989SE

Questions and answers

When was Total O2 cleared by the FDA?

Total O2 (K013472) received a 510(k) decision of Substantially Equivalent on November 28, 2001, 41 days after the submission was received.

What is the product code of K013472?

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