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510(k) K241288

Noxturnal Web by Nox Medical Ehf — Product Code OLV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2024
Date Received
May 7, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Standard Polysomnograph With Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

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  • K173868 — Serenity Body Position Sensor, Serenity RIP Sensors (July 2, 2018)
  • K173690 — Grass TWin (March 9, 2018)
  • K172986 — Zmachine Synergy (December 19, 2017)
  • K172711 — Comet-PLUS (November 3, 2017)