MySleepDash
Device Facts
| Record ID | K252338 |
|---|---|
| Device Name | MySleepDash |
| Applicant | Somnetics International, Inc. (Dba Transcend Inc) |
| Product Code | BZD · Anesthesiology |
| Decision Date | Apr 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
