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510(k) K120888

PSG-1100 SLEEP DIAGNOSTIC SYSTEM by Nihon Kohden Corp. — Product Code GWQ

K120888 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corp. for the device "PSG-1100 SLEEP DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on November 9, 2012. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Nihon Kohden Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2012
Date Received
March 23, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances by Nihon Kohden Corp.

  • K151080 — Nihon Kohden CSM 1901 Bedside Monitor (November 5, 2015)
  • K130238 — NIHON KOHDEN AE-918P NEURO UNIT (March 4, 2015)
  • K122214 — TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) (May 21, 2013)
  • K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM (September 19, 2012)
  • K112637 — NETKONNECT REMOTE NETWORK EXTENSION (December 9, 2011)
  • K110594 — GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS (October 28, 2011)
  • K110410 — MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) (August 4, 2011)
  • K110376 — PE-210AK SWITCH BOX (July 29, 2011)
  • K102106 — NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION (December 17, 2010)
  • K102376 — NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 (December 7, 2010)

Other clearances for product code GWQ

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • K260455 — New Wave System (March 13, 2026)
  • K233403 — Flexset System (April 30, 2024)
  • K231366 — Neuronaute Plus (November 9, 2023)
  • K221959 — Q21 (August 31, 2023)
  • K231457 — SPARK Scan (August 18, 2023)
  • K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)

FDA data resources