FDA.reportPublic FDA data

COSMED

Primary DI
18052400180263
Brand
COSMED
Company
C O S M E D SRL
Model
Quark C12x
Device description
The Quark C12x is a System for ECG and Stress Electrocardiography testing. ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000404000PC ECG 1200Norav Medical , Ltd.2000-11-22MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052400180263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805240018026318052400180263

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac stress exercise monitoring systemAn assembly of devices comprising a stress exercise monitoring system designed to record electrocardiograph (ECG) signals from electrodes placed on a patient's limbs and chest while the patient engages in varying degrees of exercise on a device or system of a predetermined kind, e.g., an ergometer. The system will typically analyse the recorded data, display results, monitor various functions, provide control of the workload, and give printouts, providing the clinician with a complete representation of the electrical activity of the heart, including heart rate.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39069315492support@cosmed.it

Regulatory Flags#

DUNS number
438896136
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18052400180522COSMEDQ-NRG2020-02-13
18052400180539COSMEDQ-NRG+2020-02-13
18052400180171COSMEDQuark RMR2016-09-23
18052400180201COSMEDFitmate2016-09-23
18052400180362COSMEDFitmate GS2016-09-23
18052400180034COSMEDmicroQuark2016-09-23
18052400180041COSMEDPony FX2016-09-23
18052400180058COSMEDPony FX Flowsafe2016-09-23
18052400180065COSMEDQuark SPIRO2016-09-23
18052400180072COSMEDSpiropalm2016-09-23
18052400180096COSMEDSpiropalm 6MWT2016-09-23
18052400180379COSMEDPony FX MIP/MEP2016-09-23
18052400180126COSMEDK4b22016-09-23
18052400180157COSMEDK4b22016-09-23
18052400180164COSMEDQuark PFT2016-09-23
18052400180188COSMEDQuark CPET2016-09-23
18052400180225COSMEDFitmate Pro2016-09-23
18052400180249COSMEDFitmate Med2016-09-23
18052400180287COSMEDQuark T12x2016-09-23
18052400180355COSMEDQ-Box2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
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B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08