Data / Medical devices / United States / D R Burton Healthcare, LLC
D R Burton Healthcare, LLC: FDA-registered device maker in Farmville, NC, United States, 2 510(k) clearances
D R Burton Healthcare, LLC is registered with the FDA (registration 3012970776) in Farmville, NC, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012970776
- Address
- 3936 S Fields ST, Farmville, NC, United States, 27828
- Owner or operator
- D R Burton Healthcare LLC (10052794)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 6, 2016
- Registered through
- 2026
- Brand names listed
- J-Wand, Nut & Nipple Adapter, OxyJet, OxyPAP, OxyTrainer, OxyTrainer Advantage, PocketPEP, T-Piece adaptor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Non-Measuring | ION | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Specification developer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 19, 2020 | K192000 | D R Burton OxyPAP | BWF | Substantially Equivalent | D R Burton Healthcare, LLC | accessdata.fda.gov |
| August 3, 2016 | K160636 | iPEP System and vPEP | BWF | Substantially Equivalent | D R Burton Healthcare, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- All makers of Spirometer, Therapeutic (Incentive)
- All makers of Mask, Oxygen, Low Concentration, Venturi
- All makers of Mouthpiece, Breathing
- All makers of Stylet, Tracheal Tube
- All makers of Tubing, Pressure And Accessories
Updated February 19, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.