Bunn Model 510 Medication Compressor
FDA 510(k) K862628 · The John Bunn Co.
510(k) numberK862628
Submission
- Device name
- Bunn Model 510 Medication Compressor
- Applicant
- The John Bunn Co.
Tonawanda, NY, US - Received
- July 10, 1986
- Decision date
- August 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
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| K051691 | Minimate CompressorBTI · Traditional | Precision Medical, Inc. | 12/09/2005SE |
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| K041406 | Newport C250 Air Compressor Model C250BTI · Traditional | Newport Medical Instruments | 12/15/2004SE |
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| K040220 | Medical Air CompressorBTI · Traditional | eVent Medical, Ltd. | 06/09/2004SE |
More from eVent Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K900854 | John Bunn: Medix Compact TravellerBTT · Traditional | 04/23/1990SE |
| K883216 | Bunn Model 50 Oxygen Flow ControllerNFB · Traditional | 08/18/1988SE |
| 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 |
| 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 510 Medication Compressor cleared by the FDA?
Bunn Model 510 Medication Compressor (K862628) received a 510(k) decision of Substantially Equivalent on August 7, 1986, 28 days after the submission was received.
What is the product code of K862628?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.