K190353 is an FDA 510(k) clearance for the Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac. This device is classified as a Sleep Appliances With Patient Monitoring (Class II - Special Controls, product code PLC).
Submitted by Residential Home Sleep Services (Battle Creek, US). The FDA issued a Cleared decision on April 10, 2020, 420 days after receiving the submission on February 15, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570. For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy..
| 510(k) Number | K190353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2019 |
| Decision Date | April 10, 2020 |
| Days to Decision | 420 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PLC - Sleep Appliances With Patient Monitoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |
| Definition | For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy. |