K251364
- 510(k) number
- K251364
- Device name
- Sleepiz One+ (2.5)
- Applicant
- Sleepiz AG CH
- Product code
- DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alar
- Decision date
- 2025-07-29
- Date received
- 2025-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.2 MB · U.S. public domain
Also available from FDA: K251364.pdf
Official FDA record: K251364
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.