510(k) K073491

EEG-1100A SWITCH BOX by Nihon Kohden America, Inc. — Product Code OLV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 11, 2008
Date Received: December 12, 2007
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 Nihon Kohden America, Inc.

K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX (March 22, 2012)
K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AN (March 16, 2012)
K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM (July 9, 2010)
K083456 — NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P (March 2, 2009)
K083271 — BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SER (December 24, 2008)
K082785 — NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES (November 26, 2008)
K071969 — SEN-4100 ELECTRIC STIMULATOR (October 6, 2008)
K080546 — NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A (August 29, 2008)
K073550 — PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION (March 28, 2008)
K080342 — NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES (February 26, 2008)

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)