The following data is part of a premarket notification filed by Somnetics International, Inc. with the FDA for Transcend Heated Humidifier.
| Device ID | K131388 |
| 510k Number | K131388 |
| Device Name: | TRANSCEND HEATED HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SOMNETICS INTERNATIONAL, INC. 33 5TH AVE NW, STE 500 New Brighton, MN 55112 |
| Contact | Melinda Swanson |
| Correspondent | Melinda Swanson SOMNETICS INTERNATIONAL, INC. 33 5TH AVE NW, STE 500 New Brighton, MN 55112 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-14 |
| Decision Date | 2013-09-26 |
| Summary: | summary |