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510(k) Data Aggregation

    K Number
    K162515
    Device Name
    COSMED K5 Wearable Metabolic Technology
    Manufacturer
    COSMED S.r.l.
    Date Cleared
    2017-06-20

    (285 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use. The main measurements reported by the system are Oxygen Uptake production, Ventilation, Heart Rate and Energy Expenditure. K5 is intended to use with adults and children over the age of 14 years. It is to be used by physicians or by trained personnel on a physician responsibility. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient's diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases
    Device Description
    The COSMED K5 Wearable Metabolic Technology is a portable unit, designed for the measurement of resting and exercise metabolism in the laboratory, utilizing international measurement quidelines published by relevant scientific societies. The K5 consists of the following main parts: - Main portable unit - Optional Bluetooth receiver - PC software - Face mask with head cap - Turbine flowmeter with optoelectronic reader and wind cover - Harness - Heart rate monitor belt - 02 sensor - Battery charger + batteries - AC/DC adapter - USB cable - Carrying case - Optional pressure regulator for calibration The K5 system is intended to be used the laboratory, by either direct connection or by telemetry. The system offers both 'breath-by-breath' and 'mixing chamber' operational modes.
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    K Number
    K120146
    Device Name
    QUARK SERIES
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2012-12-11

    (328 days)

    Product Code
    CBK, BTY
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    The COSMED Quark Series system is a modular system with multiple configurations.
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    K Number
    K093174
    Device Name
    SPIROPALM
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2010-02-26

    (141 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COSMED Spiropalm and Spiropalm Plus pulmonary function testing system are Spirometers for performing the basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximal Voluntary Ventilation) and Pulse Oximetry tests in the physician's office or a hospital setting.
    Device Description
    Not Found
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    K Number
    K071533
    Device Name
    FITMATE SERIES
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2007-09-28

    (115 days)

    Product Code
    BZL
    Regulation Number
    868.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.
    Device Description
    Fitmate is designed for measuring oxygen uptake at rest and during exercise (VO2max). The device is a metabolic monitor measuring Resting Metabolic Rate (RMR) and Exercise Capacity - VO2max (maximal oxygen uptake), during a sub-maximal or maximal exercise protocol. Fitmate series family includes Fitmate and Fitmate Pro. Fitmate is specifically designed for the measurement of Resting Metabolic Rate only, and Fitmate Pro includes also the measurement of maximal oxygen uptake (VO2max).
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    K Number
    K040549
    Device Name
    COSMED PONY FX
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2004-09-28

    (210 days)

    Product Code
    BTY, DQA
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 Description
    Not Found
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    K Number
    K020745
    Device Name
    COSMED MICROQUARK
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2003-01-02

    (301 days)

    Product Code
    BTY
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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 Description
    Not Found
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    K Number
    K014262
    Device Name
    COSMED QUARK C12/QUARK T12
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2002-03-26

    (89 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COSMED Quark C12 (Quark T12 in telemetric version) is an electrocardiograph designed for cardiological stress testing, or cardiopulmonary stress testing, if used integrated with a COSMED metabolic cart (Quark b², Quark PFT ergo or K4 b²).
    Device Description
    Not Found
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    K Number
    K001174
    Device Name
    COSMED QUARK
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    2001-01-11

    (275 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963373
    Device Name
    COSMED K4
    Manufacturer
    COSMED S.R.L.
    Date Cleared
    1997-09-10

    (379 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMED S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cosmed K4 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4 measures, in real conditions, the O2 consumption the CO, production and the heart rate of the person being monitored.
    Device Description
    The subject wears equipment by a harness and breathes into a face mask held on by an anatomic cap. The respiratory flow, expiratory flow, gas concentrations (02 and C02) and heart rate are measured and transmitted to the Receiver Unit. Data collected are stored for later analysis on a personal computer for which software is supplies and run in Windows Application.
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