Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004149774

FEI Number

3004149774

Entity Name

SENTEC AG

City/State/Country

THERWIL Basel-Landschaft, CH

Establishment Address

RINGSTRASSE 39, THERWIL Basel-Landschaft CH-4106, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SENTEC AG (Owner Number: 9064082)

Owner / Operator Contact Address

RINGSTRASSE 39, --, THERWIL, CH-BL CH-4106, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243765

PMA Number

N/A

All Registered Proprietary Names

SenTec Digital Monitoring System RSS Series SpO2 Soft Sensors EC-MI Ear Clip VS-A/P/N V-SignTM Sensor 2 SDMS SenTec Digital Monitoring System V-STATS PC Software including V- CareNeT MAR-SF Multi-site Attachment Ring MAR-MI Multi-site Attachment Ring 103164 tCOM+ Patient Monitor 103149 Calibration Gas tCOM+ 103421 Sensor Adapter Cable (Long) tCOM+ 103420 Sensor Adapter Cable (Regular) tCOM+ 103422 Sensor Adapter Cable (Extra Long) tCOM+ 1ST272-100 LuMon Belt 19 1ST278-100 LuMon Belt 47 1ST274-100 LuMon Belt 26 1ST282-100 LuMon Belt 80 1ST283-100 LuMon Belt 92 1ST275-100 LuMon Belt 30 2ST200-100 LuMon Monitor 1ST276-100 LuMon Belt 35 1ST277-100 LuMon Belt 40 1ST120-100 LuMon Connector 2 103583 LuMon Contact Gel 1ST273-100 LuMon Belt 22 1ST285-100 LuMon Belt 116 1ST284-100 LuMon Belt 104

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-12-16
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2010-12-29
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-12-29
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2010-12-29
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2024-06-27
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2024-06-27
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2024-06-27
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2024-06-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-06-27
QEB	Ventilatory Electrical Impedance Tomograph	Anesthesiology	Class 2	868.1505	2025-08-25

Official Correspondent

No official correspondent registered.

US Agent Details

Stephen Gorski Business: Imagenix, Inc. Email: stephengorski@me.com Phone: (414) 7374596

Related Public Records

Same Entity

SENTEC AG

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
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
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

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1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004149774. Last updated year: 2026. Please use registration number 3004149774 when referencing this establishment in official correspondence.