CEREBRALOGIK- AEEG— 510(k) K131789

Substantially Equivalent

Mennen Medical , Ltd.

FDA 510(k) clearance K131789 for CEREBRALOGIK- AEEG, Substantially Equivalent on 2013-12-27. Applicant: Mennen Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Mennen Medical , Ltd.
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2013-06-18
Decision date: 2013-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rohovot, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMA

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
K130238 — NIHON KOHDEN AE-918P NEURO UNIT2015-03-04

More clearances from Mennen Medical , Ltd.

K141441 — MENNTOR X72015-01-09
K123792 — HORIZON XVU (FFR)2013-08-30
K093766 — VITALOGIK 6000/65002010-05-07
K091165 — HORIZON XVU2009-08-07
K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS2008-12-16

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