The following data is part of a premarket notification filed by Somnice, Inc. with the FDA for The Inap One Sleep Therapy System.
| Device ID | K193460 |
| 510k Number | K193460 |
| Device Name: | The INAP One Sleep Therapy System |
| Classification | Intraoral Pressure Gradient Device |
| Applicant | Somnice, Inc. 5F, No. 22, Sec. 2, Shengyi Rd., Hsinchu Science Park, Zhubei City Hsinchu County, TW 30261 |
| Contact | Sujith Shetty |
| Correspondent | Sujith Shetty Maxis LLC 75 E. Santa Clara St. 6th Floor San Jose, CA 95113 |
| Product Code | OZR |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719878320115 | K193460 | 000 |
| 04719878320061 | K193460 | 000 |
| 04719878320023 | K193460 | 000 |
| 04719878320542 | K193460 | 000 |
| 04719878320535 | K193460 | 000 |
| 04719878320528 | K193460 | 000 |
| 04719878320108 | K193460 | 000 |
| 04719878321075 | K193460 | 000 |
| 04719878321105 | K193460 | 000 |
| 04719878320559 | K193460 | 000 |
| 04719878320887 | K193460 | 000 |
| 04719878320092 | K193460 | 000 |
| 04719878320078 | K193460 | 000 |
| 04719878320030 | K193460 | 000 |
| 04719878320009 | K193460 | 000 |
| 04719878320047 | K193460 | 000 |
| 04719878320252 | K193460 | 000 |
| 04719878320184 | K193460 | 000 |
| 04719878320511 | K193460 | 000 |
| 04719878321099 | K193460 | 000 |