The following data is part of a premarket notification filed by Fresca Medical Inc. with the FDA for Somnera System.
| Device ID | K200698 |
| 510k Number | K200698 |
| Device Name: | Somnera System |
| Classification | Positive Airway Pressure System |
| Applicant | FRESCA Medical Inc. 1291 Puerta Del Sol Suite #200 San Clemente, CA 92673 |
| Contact | Mary Lou Mooney |
| Correspondent | Mary Lou Mooney FRESCA Medical Inc. 1291 Puerta Del Sol Suite #200 San Clemente, CA 92673 |
| Product Code | QBY |
| CFR Regulation Number | 868.5273 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-17 |
| Decision Date | 2020-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810045450162 | K200698 | 000 |
| 00810045450049 | K200698 | 000 |
| 00810045450056 | K200698 | 000 |
| 00810045450063 | K200698 | 000 |
| 00810045450087 | K200698 | 000 |
| 00810045450094 | K200698 | 000 |
| 00810045450100 | K200698 | 000 |
| 00810045450131 | K200698 | 000 |
| 30810045450170 | K200698 | 000 |
| 00810045450001 | K200698 | 000 |
| 00810045450018 | K200698 | 000 |
| 00810045450032 | K200698 | 000 |
| 00810045450070 | K200698 | 000 |
| 00810045450117 | K200698 | 000 |
| 00810045450025 | K200698 | 000 |