The following data is part of a premarket notification filed by Zephyr Sleep Technologies, Inc. with the FDA for Td Clip.
| Device ID | K190051 |
| 510k Number | K190051 |
| Device Name: | TD Clip |
| Classification | Device, Anti-snoring |
| Applicant | Zephyr Sleep Technologies, Inc. 102, 701 64 Ave SE Calgary, CA T2h 2c3 |
| Contact | Sabina Bruehlmann |
| Correspondent | Sabina Bruehlmann Zephyr Sleep Technologies, Inc. 102, 701 64 Ave SE Calgary, CA T2h 2c3 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-11 |
| Decision Date | 2019-06-07 |