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 a medical device manufactured by Ambulatory Monitoring, Inc.. It received FDA 510(k) clearance on 2025-07-31 under approval 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. It is manufactured by Ambulatory Monitoring, Inc.. The 510(k) number is K251574.
When was Sleep Watch approved by the FDA?
Sleep Watch received FDA 510(k) clearance on 2025-07-31, under approval number K251574.
What company makes Sleep Watch?
Sleep Watch is manufactured by Ambulatory Monitoring, Inc..
What is the FDA product code for Sleep Watch?
The FDA product code for Sleep Watch is LEL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.