Sleep Watch— 510(k) K251574

Substantially Equivalent

Ambulatory Monitoring, Inc.

FDA 510(k) clearance K251574 for Sleep Watch, Substantially Equivalent on 2025-07-31. Applicant: Ambulatory Monitoring, Inc..

Clearance details

Applicant: Ambulatory Monitoring, Inc.
Product code: Code LEL
Advisory panel: Neurology
Date received: 2025-05-22
Decision date: 2025-07-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Ardsley, NY, US

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