Sleep Watch— 510(k) K251574
Substantially EquivalentAmbulatory Monitoring, Inc.
FDA 510(k) clearance K251574 for Sleep Watch, Substantially Equivalent on 2025-07-31. Applicant: Ambulatory Monitoring, Inc.. Device class: 2.
Clearance details
- Applicant
- Ambulatory Monitoring, Inc.
- Product code
- Code LEL
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ardsley, NY, US
Recent devices under product code LEL
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