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The COSMED Quark Series system is a modular system with multiple configurations, allowing the following the following the final The COSMED Quart Senes System is a modular of the max maxple only and only in the managements. The system and its accessories are indicated for the acquisition, analysis, to display, printing and The system and its accessories are molcated for the acquisition in the diagnosis of carry of cardio-purnonary disease conditions.

Quark SPIRO: Pulmonary Function testing - Age 6 to adults
Quark PFT: Pulmonary Function testing - Age 6 to adults; Cardiopulmonary Exercise testing - age 6 to adults
Quark CPET: Pulmonary Function testing - Age 6 to adults; Cardiopulmonary Exercise testing - age 6 to adults
Quark RMR: Measurement of Resting Metabolism (face mask) - age 6 to adults; Measurement of Resting Metabolism (canopy dilution) -15Kg/30Lb to adults: Measurement of Resting Metabolism (Ventilated patients) - age 10 to adults

Specific Indications for use: Quark SPIRO and Quark PFT also allows the Airways Resistance Test with the occlusion technique (Rocc test) for young patients from 3 to 6 years old.

The COSMED Quark Series system is a modular system with multiple configurations.

The provided text is related to a 510(k) premarket notification for a medical device (Cosmed S.R.L.'s Quark Series). It primarily focuses on the FDA's determination of substantial equivalence and the device's indications for use.

Crucially, the document does NOT contain information about acceptance criteria, detailed study designs, performance metrics, ground truth establishment, or sample sizes for testing or training sets.

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The document discusses the regulatory classification and general requirements but does not delve into the technical validation or clinical study data that would demonstrate the device meets performance criteria.

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