The following data is part of a premarket notification filed by D R Burton Healthcare Llc with the FDA for Ipep System And Vpep.
| Device ID | K160636 |
| 510k Number | K160636 |
| Device Name: | IPEP System And VPEP |
| 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 | 2016-03-07 |
| Decision Date | 2016-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851232007722 | K160636 | 000 |
| 30851232007685 | K160636 | 000 |
| 10851232007551 | K160636 | 000 |
| 10851232007568 | K160636 | 000 |
| 10851232007520 | K160636 | 000 |
| 10851232007025 | K160636 | 000 |
| 10851232007018 | K160636 | 000 |