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
Prescription Use : Yes
Device Description : The device is intended for use in clinical and research application to measure o The device is intended for use in clinical and research application to measure oxygen uptake. Fitmate is designed for the measurement of Resting Metabolic Rate only.
Device Class : 2
Duns Number: 438896136
Premarket Exempt : No
Prescription Use : Yes
Device Description : This device is intended for use in clinical and research application to measure This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate Pro is designed for the measurement of Resting Metabolic Rate and maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.
Device Class : 2
Duns Number: 438896136
Premarket Exempt : No
Prescription Use : Yes
Device Description : This device is intended for use in clinical and research application to measure This device is intended for use in clinical and research application to measure oxygen uptake.
Device Class : 2
Duns Number: 438896136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Quark C12x is a System for ECG and Stress Electrocardiography testing. ECG i 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.
Device Class : 2
Duns Number: 438896136
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Quark T12x is an ECG system that is intended to disclose either normal condi The Quark T12x is an ECG system that is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischeria, rate abnormalities, or features of prognostic value in patients.
Device Class : 2
Duns Number: 438896136
Premarket Exempt : No
Prescription Use : Yes
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
Prescription Use : Yes
Device Description : This device is intended for use in clinical and research application to measure This device is intended for use in clinical and research application to measure oxygen uptake.
Device Class : 2
Duns Number: 438896136
Premarket Exempt : No
Prescription Use : Yes
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
Prescription Use : Yes
Device Class : 2
Duns Number: 438896136
Premarket Exempt : No
Prescription Use : Yes