510(k) K161650

Polysmith Sleep System, Model NTI7593 by Neurotronics, Inc. — Product Code OLV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 19, 2017
Date Received: June 15, 2016
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.

Other clearances by Neurotronics, Inc.

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K220631 — NomadAir PMU810 (July 15, 2022)
K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor (November 16, 2018)
K173868 — Serenity Body Position Sensor, Serenity RIP Sensors (July 2, 2018)
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 OLV

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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)