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FDA 510(k)

Sleep Watch

K-Number: K251574 · 2025-07-31

ApplicantAmbulatory Monitoring, Inc.
Decision Date2025-07-31
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sleep Watch is the device name listed in this FDA 510(k) record. The listed applicant is Ambulatory Monitoring, Inc.. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K251574. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sleep Watch?

Sleep Watch is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Ambulatory Monitoring, Inc.. The 510(k) number is K251574.

When did Sleep Watch receive FDA 510(k) clearance?

Sleep Watch received FDA 510(k) clearance on 2025-07-31, under 510(k) number K251574.

Who is the listed applicant for Sleep Watch?

The FDA 510(k) record lists Ambulatory Monitoring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sleep Watch?

The FDA product code for Sleep Watch is LEL.

Related Devices (Code: LEL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252981EmbraceMiniEmpatica S.r.l.K243513DCM (PW-DCM)Pneumowave, Ltd.K233987VERABAND™Arbor Medical Innovations, LLCK233618Oxevision Sleep DeviceOxehealth LimitedK231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLCK181077ActiGraph CentrePoint Insight WatchActigraph

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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