K251920
- 510(k) number
- K251920
- Device name
- Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
- Applicant
- Dcstar, Inc. NY · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2026-05-21
- Date received
- 2025-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251920.pdf
Official FDA record: K251920
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.