K251574
- 510(k) number
- K251574
- Device name
- Sleep Watch
- Applicant
- Ambulatory Monitoring, Inc. NY · US
- Product code
- LEL — Device, Sleep Assessment
- Decision date
- 2025-07-31
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251574.pdf
Official FDA record: K251574
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.