Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042165671

FEI Number

3042165671

Entity Name

NEKO HEALTH AB

City/State/Country

Danderyd Stockholm, SE

Establishment Address

Svardvagen 19, Danderyd Stockholm 182 33, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neko Health AB (Owner Number: 10094483)

Owner / Operator Contact Address

Svardvagen 19, Danderyd, SE-AB 182 33, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213957

PMA Number

N/A

All Registered Proprietary Names

Spectrum-2 Positioner-1 Derma-2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2026-05-28
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2026-06-18
FTT	Camera, Still, Surgical	General, Plastic Surgery	Class 1	878.4160	2026-05-28
LHQ	System, Telethermographic (Adjunctive Use)	Obstetrics/Gynecology	Class 1	884.2980	2026-05-28
PSN	Light Based Imaging	General, Plastic Surgery	Class 2	878.4580	2025-12-05

Official Correspondent

Per Sundstrom

US Agent Details

Doug Lane Business: Neko Health Inc Email: douglas.lane@nekohealth.com Phone: (323) 3957237

Related Public Records

Same Entity

Neko Health AB

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
K201432	Masimo Corporation	Masimo O3 Regional Oximeter System	2020-08-29
K211561	Covidien, LLC	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)	2021-12-05

Similar Registrations

Registration Number	Establishment Name	Location
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3007616088	JIANGYIN SINBON ELECTRONICS CO LTD	Jiangyin Jiangsu, CN
3009673645	SOTERA WIRELESS	Carlsbad, CA, US
3010611950	Natus Neurology Incorporated	Middleton, WI, US
3004105270	PLEXUS CORP.	BUFFALO GROVE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042165671. Last updated year: 2026. Please use registration number 3042165671 when referencing this establishment in official correspondence.