Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011047165

FEI Number

3011047165

Entity Name

Kvikna Medical ehf

City/State/Country

Reykjavik, IS

Establishment Address

Lynghals 9, Reykjavik 110, IS

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Kvikna Medical ehf (Owner Number: 10051556)

Owner / Operator Contact Address

Lynghals 9, Reykjavik, IS-55 110, IS

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143487

PMA Number

N/A

All Registered Proprietary Names

Stratus EEG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2016-04-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2016-04-04

Official Correspondent

Gardar Thorvardsson

US Agent Details

David Hruda Business: Stratus Email: david@stratusneuro.com Phone: (301) 7525700

Related Public Records

Same Entity

Kvikna Medical ehf

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
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

Similar Registrations

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3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
3008773490	PAUL E. DANCHELL A/S	Jyderup Sjalland, DK
9611252	NIHON KOHDEN CORP.	SHINJUKU-KU Tokyo, JP
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011047165. Last updated year: 2026. Please use registration number 3011047165 when referencing this establishment in official correspondence.