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510(k) K220631

NomadAir PMU810 by Neurotronics, Inc. — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2022
Date Received
March 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

Other clearances by Neurotronics, Inc.

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  • K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor (November 16, 2018)
  • K173868 — Serenity Body Position Sensor, Serenity RIP Sensors (July 2, 2018)
  • K161650 — Polysmith Sleep System, Model NTI7593 (January 19, 2017)
  • K142774 — Polysmith Sleep System (February 18, 2015)
  • K131415 — LIVE VIEW PANEL (LVP) (August 9, 2013)
  • K092699 — NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 (March 18, 2010)
  • K062943 — POLYSMITH SLEEP SYSTEM, MODEL NTI5498 (May 9, 2007)
  • K971803 — NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 (November 12, 1997)

Other clearances for product code GWL

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  • K242832 — NExT Station; NExT Station Advanced (December 12, 2024)
  • K242305 — BE Plus PRO, Neurotravel LIGHT (September 4, 2024)
  • K240646 — DreamClear (September 4, 2024)
  • K232210 — X-trodes System M (February 4, 2024)
  • K230148 — Vlab (October 11, 2023)
  • K223676 — SomniCheck (June 1, 2023)
  • K203331 — Quick-20m (May 20, 2021)
  • K202174 — Digital NeuroPort Biopotential Signal Processing System (February 10, 2021)
  • K201747 — 8-CH Electroencephalography Amplifier (December 27, 2020)