Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014886121

FEI Number

3014886121

Entity Name

INTOPS CO.,LTD.

City/State/Country

Suwon Gyeonggi, KR

Establishment Address

97, Sanup-Ro, Gwonseon-ward, Suwon Gyeonggi 16642, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

INTOPS Co.,Ltd. (Owner Number: 10059242)

Owner / Operator Contact Address

97, Sanup-Ro, Gwonseon-ward, Suwon, KR-41 16642, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2024-12-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-12-19
POS	Physiological Signal Based Seizure Monitoring System	Neurology	Class 2	882.1580	2024-12-19
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-12-29
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-12-29
POS	Physiological Signal Based Seizure Monitoring System	Neurology	Class 2	882.1580	2025-12-11
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-11-23
POS	Physiological Signal Based Seizure Monitoring System	Neurology	Class 2	882.1580	2018-12-14

Official Correspondent

Jong su Lee

US Agent Details

Matteo Lai Business: Empatica Inc. Email: ml@empatica.com Phone: (415) 5483860

Related Public Records

Same Entity

INTOPS Co.,Ltd.

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

Similar Registrations

Registration Number	Establishment Name	Location
3012933969	EMPATICA S.r.l.	Milano, IT
3012324979	SHENZHEN FENDA TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
3020018	CADWELL INDUSTRIES, INC.	KENNEWICK, WA, US
3013896610	Hypertec HCM LLC	Plainfield, IN, US
3033715634	HAPPY HEALTH	Austin, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014886121. Last updated year: 2026. Please use registration number 3014886121 when referencing this establishment in official correspondence.