K253388
- 510(k) number
- K253388
- Device name
- Sleepiz One+ (Model 2.5)
- Applicant
- Sleepiz AG CH
- Product code
- DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alar
- Decision date
- 2026-01-28
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253388.pdf
Official FDA record: K253388
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.