The following data is part of a premarket notification filed by D R Burton Healthcare, Llc with the FDA for D R Burton Oxypap.
| Device ID | K192000 |
| 510k Number | K192000 |
| Device Name: | D R Burton OxyPAP |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | D R Burton Healthcare, LLC 3936 S Fields St Farmville, NC 27828 |
| Contact | Dennis Cook |
| Correspondent | Paul Dryden D R Burton Healthcare, LLC 3936 S Fields St Farmville, NC 27828 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-26 |
| Decision Date | 2020-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851232007711 | K192000 | 000 |
| 50851232007757 | K192000 | 000 |