Bunn Model 50 Oxygen Flow Controller
FDA 510(k) K883216 · The John Bunn Co.
510(k) numberK883216
Submission
- Device name
- Bunn Model 50 Oxygen Flow Controller
- Applicant
- The John Bunn Co.
Tonawanda, NY, US - Received
- July 29, 1988
- Decision date
- August 18, 1988
- 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
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| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileNFB · Traditional | Effortless Oxygen, LLC | 10/17/2022SE |
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| 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 |
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| 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 |
|---|---|---|
| K900854 | John Bunn: Medix Compact TravellerBTT · Traditional | 04/23/1990SE |
| K873071 | Bunn Concentrator Model 2100 SeriesCAW · Traditional | 09/15/1987SE |
| K870094 | Bunn Model 530 AspiratorBTA · Traditional | 03/06/1987SE |
| K861435 | Bunn Concentrator Model 2011 with Demand ValveCAW · Traditional | 11/07/1986SE |
| K861199 | Bunn Model 22 Oxygen Flow ControllerNFB · Traditional | 08/26/1986SE |
| K862628 | Bunn Model 510 Medication CompressorBTI · Traditional | 08/07/1986SE |
| K855208 | Bunn Lite Oxygen ConcentratorCAW · Traditional | 02/21/1986SE |
| K860060 | RX02 Plus Oxygen ConcentratorCAW · Traditional | 02/05/1986SE |
| K843811 | Bunn 3001 Oxygen ConcentratorCAW · Traditional | 10/04/1984SE |
| K841102 | Bunn 1000 Oxygen ConcentratorCAW · Traditional | 04/13/1984SE |
Questions and answers
When was Bunn Model 50 Oxygen Flow Controller cleared by the FDA?
Bunn Model 50 Oxygen Flow Controller (K883216) received a 510(k) decision of Substantially Equivalent on August 18, 1988, 20 days after the submission was received.
What is the product code of K883216?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.