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510(k) Data Aggregation
K Number
K162515Device Name
COSMED K5 Wearable Metabolic Technology
Manufacturer
COSMED S.r.l.
Date Cleared
2017-06-20
(285 days)
Product Code
BZC
Regulation Number
868.1880Why 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
K120146Device Name
QUARK SERIES
Manufacturer
COSMED S.R.L.
Date Cleared
2012-12-11
(328 days)
Product Code
CBK, BTY
Regulation Number
868.5895Why 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
K093174Device Name
SPIROPALM
Manufacturer
COSMED S.R.L.
Date Cleared
2010-02-26
(141 days)
Product Code
BZG
Regulation Number
868.1840Why 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
K071533Device Name
FITMATE SERIES
Manufacturer
COSMED S.R.L.
Date Cleared
2007-09-28
(115 days)
Product Code
BZL
Regulation Number
868.1730Why 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
K040549Device Name
COSMED PONY FX
Manufacturer
COSMED S.R.L.
Date Cleared
2004-09-28
(210 days)
Product Code
BTY, DQA
Regulation Number
868.1890Why 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
K020745Device Name
COSMED MICROQUARK
Manufacturer
COSMED S.R.L.
Date Cleared
2003-01-02
(301 days)
Product Code
BTY
Regulation Number
868.1890Why 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
K014262Device Name
COSMED QUARK C12/QUARK T12
Manufacturer
COSMED S.R.L.
Date Cleared
2002-03-26
(89 days)
Product Code
DPS
Regulation Number
870.2340Why 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
K001174Device Name
COSMED QUARK
Manufacturer
COSMED S.R.L.
Date Cleared
2001-01-11
(275 days)
Product Code
BZC
Regulation Number
868.1880Why 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
K963373Device Name
COSMED K4
Manufacturer
COSMED S.R.L.
Date Cleared
1997-09-10
(379 days)
Product Code
BZC
Regulation Number
868.1880Why 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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