510(k) K992291

H20- TETHERED OPTION by Grass-Telefactor Product Group — Product Code OLV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 6, 1999
Date Received: July 7, 1999
Clearance Type: Special
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 Grass-Telefactor Product Group

K974583 — DEEGLITE (June 9, 1998)
K974587 — H2O (March 9, 1998)
K972202 — DEEG-LITE (July 23, 1997)
K925838 — TELEFACTOR D/EEG-32 (April 30, 1993)
K884937 — BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (April 14, 1989)
K870432 — A1-A2 AMBULATORY EEG CASSETTE RECORDER (May 8, 1987)
K871480 — STD-228 SPECTRAL TREND DISPLAY (May 1, 1987)
K870450 — SZAC-16 SEIZURE ANALYSIS COMPUTER (April 8, 1987)
K870381 — DD-VCR-64 (March 25, 1987)
K860219 — SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM (April 17, 1986)

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K213007 — Cerebra Sleep System (July 6, 2022)
K201054 — SOMNOscreen plus (August 12, 2020)
K192624 — ApneaTrak (February 20, 2020)
K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor (November 16, 2018)
K173868 — Serenity Body Position Sensor, Serenity RIP Sensors (July 2, 2018)
K173690 — Grass TWin (March 9, 2018)
K172986 — Zmachine Synergy (December 19, 2017)