ActiGraph LEAP activity monitor (ActiGraph LEAP)— 510(k) K231532

Name: FDA 510(k) clearance K231532
Creator: U.S. Food and Drug Administration
Published: 2023-06-23

Substantially Equivalent

Actigraph, LLC

FDA 510(k) clearance K231532 for ActiGraph LEAP activity monitor (ActiGraph LEAP), Substantially Equivalent on 2023-06-23. Applicant: Actigraph, LLC. Device class: 2.

Clearance details

Applicant: Actigraph, LLC
Product code: Code LEL
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2023-05-26
Decision date: 2023-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Pensacola, FL, US

Download summary PDF View on FDA.gov ↗

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