K252338
- 510(k) number
- K252338
- Device name
- MySleepDash
- Applicant
- Somnetics International, Inc. (Dba Transcend Inc) MN · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2026-04-17
- Date received
- 2025-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.0 MB · U.S. public domain
Also available from FDA: K252338.pdf
Official FDA record: K252338
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.