Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007389703

FEI Number

3007389703

Entity Name

NOX MEDICAL

City/State/Country

Reykjavik, IS

Establishment Address

Katrinartuni 2, Reykjavik IS-105, IS

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nox Medical (Owner Number: 10027652)

Owner / Operator Contact Address

Katrinartuni 2, Reykjavik, IS-55 IS-105, IS

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252330

PMA Number

N/A

All Registered Proprietary Names

Noxturnal Web DeepRESP Somryst Somryst - CBT - I Nox A1 System Noxturnal PSG CD Nox A1 Recorder Noxturnal US Nox A1 EEG 5 Lead Gold Electrode Cable Noxturnal PSG Noxturnal App Nox A1 EEG Head Cable Nox C1 Access Point Nox A1 Carry Case Noxturnal US CD Nox C1 Kit Nox A1 Starter Sensor Kit, Pediatric Nox A1 Starter Sensor Kit, Adult Nox C1s Kit Nox A1s System Noxturnal US App Nox A1s Recorder Nox RIP Belts Disposable X-Large 1 set Nox RIP Belts Disposable Medium 20 sets Nox RIP Belts Disposable Pediatric 1 set Nox RIP Belts Disposable Large 1 set Nox RIP Belts and Cannula Kit M Nox T3® Demo System Nox RIP Belts Disposable Small 1 set Nox T3® System Nox RIP Belts Disposable X-Large 14 sets Nox RIP Belts Disposable Large 20 sets Nox RIP Belts Disposable Medium 1 set Nox RIP Belts Disposable Pediatric 20 sets Nox RIP Belts Disposable Small 20 sets Nox RIP Belts and Cannula Kit S/M/L Nox Abdomen Cable - NOX-ATC1PAC1 Nox Abdomen Cable, s DeepRESP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2025-06-03
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2025-06-04
QVO	Computerized Behavioral Therapy Device For Insomnia	Neurology	Class 2	882.5801	2024-12-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-12-04
KZM	Device, Muscle Monitoring	Physical Medicine	Class 2	890.1375	2020-02-14
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2020-02-14
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2015-11-25
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2025-12-18

Official Correspondent

Robert Magnusson

US Agent Details

Sigurjon Kristjansson Business: Nox Health Email: sk@fusionhealth.com Phone: (888) 5050280

Related Public Records

Same Entity

Nox Medical

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
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653

Similar Registrations

Registration Number	Establishment Name	Location
3005733633	EPM GLOBAL SERVICES INC., DBA VEXOS	Markham Ontario, CA
3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
2080783	NIHON KOHDEN AMERICA, INC.	Irvine, CA, US
3006125362	NEUROVIRTUAL USA, INC.	Fort Lauderdale, FL, US
3026753386	ONERA B.V.	Eindhoven Noord-Brabant, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007389703. Last updated year: 2026. Please use registration number 3007389703 when referencing this establishment in official correspondence.