C O S M E D SRL

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Device Description : The COSMED microQuark pulmonary function testing system is a modular laboratory The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation).

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, BZC

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The COSMED Pony FX pulmonary function testing system is a standalone and modular The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : DQA, BTY

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The COSMED Pony FX pulmonary function testing system is a standalone and modular The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : DQA, BTY

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, CBK

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The COSMED Spiropalm pulmonary function testing systems are spirometers for perf The COSMED Spiropalm pulmonary function testing systems are spirometers for performing the basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and Pulse Oximetry tests on population from 4-6 years old to older population in the physician's office or a hospital setting.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The COSMED Spiropalm pulmonary function testing systems are spirometers for perf The COSMED Spiropalm pulmonary function testing systems are spirometers for performing the basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and Pulse Oximetry tests on population from 4-6 years old to older population in the physician's office or a hospital setting.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitori The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4b2 measures, in real conditions, the ventilation, the O2 consumption the CO2 production and the heart rate of the person being monitored.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZC

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitori The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4b2 measures, in real conditions, the ventilation, the O2 consumption the CO2 production and the heart rate of the person being monitored.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BZC

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, CBK

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The COSMED Quark Series system Is a modular system with multiple configurations, The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.

Device Class : 2

Duns Number: 438896136

Premarket Exempt : No

Product Code : BTY, CBK

Prescription Use : Yes

Device Count : 1