The following data is part of a premarket notification filed by Residential Home Sleep Services with the FDA for Bfit Sleep, Bfit Sleep With Dentitrac, Bfit Engage, Bfit Engage With Dentitrac.
| Device ID | K190353 |
| 510k Number | K190353 |
| Device Name: | Bfit Sleep, Bfit Sleep With DentiTrac, Bfit Engage, Bfit Engage With DentiTrac |
| Classification | Sleep Appliances With Patient Monitoring |
| Applicant | Residential Home Sleep Services 4602 Beckley Road Battle Creek, MI 49015 -7932 |
| Contact | Chris Gillette |
| Correspondent | Chris Gillette Residential Home Sleep Services 4602 Beckley Road Battle Creek, MI 49015 -7932 |
| Product Code | PLC |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2020-04-10 |