The following data is part of a premarket notification filed by Somnetics International, Inc. with the FDA for Transcend 365 Minicpap System.
| Device ID | K180388 |
| 510k Number | K180388 |
| Device Name: | Transcend 365 MiniCPAP System |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Somnetics International, Inc. 33 5th Ave NW, Suite 500 New Brighton, MN 55112 |
| Contact | Eric Becker |
| Correspondent | Melinda Swanson Bluebird Consulting, LLC 100 NE 2nd St. #340 Minneapolis, MN 55413 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-13 |
| Decision Date | 2018-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9505031020 | K180388 | 000 |
| M9505031010 | K180388 | 000 |
| M9505030980 | K180388 | 000 |