NightWatch+ US— 510(k) K243199

Substantially Equivalent

Livassured BV

FDA 510(k) clearance K243199 for NightWatch+ US, Substantially Equivalent on 2025-07-12. Applicant: Livassured BV. Device class: 2.

Clearance details

Applicant
Livassured BV
Product code
Code POS
Device class
Class 2
Regulation
21 CFR 882.1580
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Leiden, NL
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