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510(k) K073491

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

K073491 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "EEG-1100A SWITCH BOX". The FDA issued a decision of Substantially Equivalent on January 11, 2008. The device falls under product code OLV (Standard Polysomnograph With Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.

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

  • K260585 — Noxturnal Web (March 20, 2026)
  • 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)

FDA data resources