The following data is part of a premarket notification filed by Prosomnous Sleep Technologies with the FDA for Prosomnus [ca] Sleep And Snore Device And Prosomnus [ca] Sleep And Snore Device With Micro-recorder.
| Device ID | K172859 |
| 510k Number | K172859 |
| Device Name: | Prosomnus [CA] Sleep And Snore Device And Prosomnus [CA] Sleep And Snore Device With Micro-recorder |
| Classification | Sleep Appliances With Patient Monitoring |
| Applicant | Prosomnous Sleep Technologies 5860 W. Las Positas Blvd., Suite 25 Pleasanton, CA 94588 |
| Contact | David Kuhns |
| Correspondent | David Kuhns Prosomnous Sleep Technologies 5860 W. Las Positas Blvd., Suite 25 Pleasanton, CA 94588 |
| Product Code | PLC |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-20 |
| Decision Date | 2017-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863039000454 | K172859 | 000 |
| 00863039000409 | K172859 | 000 |