KONAN MEDICAL USA, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3005955744

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005955744
FEI Number
3005955744
Entity Name
KONAN MEDICAL USA, INC.
City/State/Country
Irvine, CA, US
Establishment Address
15770 Laguna Canyon Road, Suite 150, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KONAN MEDICAL USA, INC. (Owner Number: 10027489)
Owner / Operator Contact Address
15770 LAGUNA CANYON ROAD, SUITE 150, Irvine, CA 92618, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K081591
PMA Number
N/A

All Registered Proprietary Names

EYEKINETIX M339 DME CARBON CL M379 DME CARBON R CHINREST EVOKEDx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRI Pupillograph Ophthalmic Class 1 886.1690 2011-11-07
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-10-25
HMG Stand, Instrument, Ophthalmic, Non-Powered Ophthalmic Class 1 886.1860 2025-11-24
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2015-03-27

Official Correspondent

DALE SADLIK

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KONAN MEDICAL USA, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005955744. Last updated year: 2026. Please use registration number 3005955744 when referencing this establishment in official correspondence.
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