OXYMATIC-24
FDA 510(k) K884562 · Chad Therapeutics, Inc.
510(k) numberK884562
Submission
- Device name
- OXYMATIC-24
- Applicant
- Chad Therapeutics, Inc.
Chatsworth, CA, US - Received
- October 31, 1988
- Decision date
- January 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NFB – Conserver, Oxygen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
Other 510(k)s with product code NFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250322 | Respond OC Conserving Regulator (130-0800)NFB · Traditional | Responsive Respiratory | 07/24/2025SE |
| K220591 | ProximaNFB · Traditional | Dynasthetics, LLC | 12/15/2022SE |
| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileNFB · Traditional | Effortless Oxygen, LLC | 10/17/2022SE |
| K200401 | ApogeeNFB · Traditional | Incoba Ltd D/B/A Dynaris | 11/14/2020SE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional | Salter Labs | 03/11/2016SE |
| K131023 | Theraflow Single Lumen and Theraflow Dual LumenNFB · Traditional | Medical Products, LLC | 10/11/2013SE |
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | Inovo, Inc. | 12/08/2011SE |
| K103392 | Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special | Inovo, Inc. | 12/17/2010SE |
| K090421 | Model 350G Gas ConserverNFB · Traditional | Inspired Technologies, Inc. | 05/29/2009SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | Chad Therapeutics, Inc. | 05/07/2007SE |
More from Chad Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081176 | FlochannelMNR · Traditional | 07/28/2008SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | 05/07/2007SE |
| K042142 | Chad Therapeutics Lotus, Models OM-700 and OM-700SNFB · Special | 09/20/2004SE |
| K033364 | Chad Therapeutics SageNFB · Traditional | 05/11/2004SE |
| K020475 | Chad Therapeutics Oxypenumatic Cypress Model 511NFB · Traditional | 07/05/2002SE |
| K013472 | Total O2CAW · Traditional | 11/28/2001SE |
| K010389 | Chad Therapeutics Oxymatic Model 401 and Oxymatic Model 411NFB · Special | 03/23/2001SE |
| K003455 | Modification to Chad Therapeutics Oxymatic Model 401NFB · Special | 12/06/2000SE |
| K000890 | Chad Therapeutics Oxymatic Model 401NFB · Traditional | 06/16/2000SE |
| K971889 | Chad Total O2 Delivery SystemCAW · Traditional | 11/17/1997SE |
Questions and answers
When was OXYMATIC-24 cleared by the FDA?
OXYMATIC-24 (K884562) received a 510(k) decision of Substantially Equivalent on January 9, 1989, 70 days after the submission was received.
What is the product code of K884562?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.