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510(k) K251574

Sleep Watch by Ambulatory Monitoring, Inc. — Product Code LEL

K251574 is an FDA 510(k) premarket notification submitted by Ambulatory Monitoring, Inc. for the device "Sleep Watch". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Ambulatory Monitoring, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2025
Date Received
May 22, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Ambulatory Monitoring, Inc.

  • K894044 — ACTILLUME (December 22, 1989)
  • K854030 — WRIST ACTIGRAPH (June 25, 1986)

Other clearances for product code LEL

  • K252981 — EmbraceMini (December 22, 2025)
  • K243513 — DCM (PW-DCM) (April 16, 2025)
  • K233987 — VERABAND™ (June 17, 2024)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K151784 — ActTrust (May 25, 2016)
  • K132764 — MOTION WATCH AND PRO-DIARY (January 21, 2014)
  • K111514 — SBV2, MULTICHARGER MODEL MC10V2 (December 16, 2011)
  • K040986 — CADWELL LIMB MOVEMENT MODULE (July 1, 2004)

FDA data resources