Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038761440

FEI Number

3038761440

Entity Name

Corsano Health SA

City/State/Country

Plan-les-Ouates Geneve, CH

Establishment Address

Chemin de Pre' Fleuri 5, Plan-les-Ouates Geneve 1228, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Corsano Health B.V. (Owner Number: 10090535)

Owner / Operator Contact Address

The Hague Tech Office 1.07, Waldorpstraat 5, The Hague, NL-ZH 2521 CA, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232548

PMA Number

N/A

All Registered Proprietary Names

Charge Station 10 Sensors A Strap Silicon blue CardioWatch 287-2 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-10
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-04-10
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-04-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-10
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-04-10
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2024-04-10
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-04-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-10

Official Correspondent

Peter Stas

US Agent Details

Stephan Toupin Business: DAWA Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Corsano Health B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027510187	CORSANO HEALTH B.V.	The Hague Zuid-Holland, NL

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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3014652024	CEA GROUP INTERNATIONAL CO.,LTD	Wenzhou Zhejiang, CN
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 3038761440. Last updated year: 2026. Please use registration number 3038761440 when referencing this establishment in official correspondence.