K192127 is an FDA 510(k) clearance for the Respire Pink AT (Hard, Hard/Soft, EF). This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Respire Medical Holdings (Brooklyn, US). The FDA issued a Cleared decision on February 5, 2020, 183 days after receiving the submission on August 6, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K192127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2019 |
| Decision Date | February 05, 2020 |
| Days to Decision | 183 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |