NIHON KOHDEN AE-918P NEURO UNIT— 510(k) K130238

Name: FDA 510(k) clearance K130238
Creator: U.S. Food and Drug Administration
Published: 2015-03-04

Substantially Equivalent

Nihon Kohden Corp.

FDA 510(k) clearance K130238 for NIHON KOHDEN AE-918P NEURO UNIT, Substantially Equivalent on 2015-03-04. Applicant: Nihon Kohden Corp.. Device class: 2.

Clearance details

Applicant: Nihon Kohden Corp.
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2013-01-31
Decision date: 2015-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMA

view all

K192889 — Neo2020-01-30
K163644 — Nihon Kohden QP-160AK EEG Trend Program2017-05-19
K161027 — Cadwell AmpliScan2016-11-08
K152301 — Background Pattern Classification [BPc(TM)]2016-06-03
K131789 — CEREBRALOGIK- AEEG2013-12-27

More clearances from Nihon Kohden Corp.

view all

K122214 — TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)2013-05-21
K120888 — PSG-1100 SLEEP DIAGNOSTIC SYSTEM2012-11-09
K120397 — MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM2012-09-19
K110594 — GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS2011-10-28
K110410 — MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)2011-08-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.