The following data is part of a premarket notification filed by Prosomnus Sleep Technologies with the FDA for Prosomnus Evo [ph] Sleep And Snore Device, Prosomnus Evo [ph] Sleep And Snore Device With Patient Monitoring.
| Device ID | K221889 |
| 510k Number | K221889 |
| Device Name: | ProSomnus EVO [PH] Sleep And Snore Device, ProSomnus EVO [PH] Sleep And Snore Device With Patient Monitoring |
| Classification | Device, Anti-snoring |
| Applicant | ProSomnus Sleep Technologies 5860 W Las Positas Blvd. Suite 25 Pleasanton, CA 94588 |
| Contact | Divya Mavalli |
| Correspondent | Divya Mavalli ProSomnus Sleep Technologies 5860 W Las Positas Blvd. Suite 25 Pleasanton, CA 94588 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-29 |
| Decision Date | 2022-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850022853029 | K221889 | 000 |
| 00850022853012 | K221889 | 000 |