510(k) K970951

GRASS BRAINWAVE SOFTWARE by Astro-Med, Inc. — Product Code OLV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 19, 1997
Date Received: March 14, 1997
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 Astro-Med, Inc.

K081551 — TWIN NEUROTRAC-III (December 24, 2008)
K050425 — AURA-PSG (October 20, 2005)
K033978 — ADAM (February 18, 2004)
K963669 — GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM (December 12, 1996)
K934644 — K3 SYSTEM (November 1, 1994)
K912929 — DASH IV (August 13, 1991)
K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
K894295 — ASTRO-MED ASC-951 PRESSURE PROCESSOR (January 18, 1990)
K894736 — MT96000 PAPER CHART RECORDER (December 13, 1989)
K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)

Other clearances for product code OLV

K242447 — Falcon HST (February 20, 2025)
K241288 — Noxturnal Web (December 23, 2024)
K240700 — HomeSleepTest (HST, HST REM+) (December 8, 2024)
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)