FDA.reportPublic FDA data

COSMED

Primary DI
18052400180126
Brand
COSMED
Company
C O S M E D SRL
Model
K4b2
Device description
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963373000COSMED K4Cosmed Srl1997-09-10BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18052400180126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805240018012618052400180126

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary stress exercise monitoring systemAn assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39069315492support@cosmed.it

Regulatory Flags#

DUNS number
438896136
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18052400180522COSMEDQ-NRG2020-02-13
18052400180539COSMEDQ-NRG+2020-02-13
18052400180171COSMEDQuark RMR2016-09-23
18052400180201COSMEDFitmate2016-09-23
18052400180362COSMEDFitmate GS2016-09-23
18052400180034COSMEDmicroQuark2016-09-23
18052400180041COSMEDPony FX2016-09-23
18052400180058COSMEDPony FX Flowsafe2016-09-23
18052400180065COSMEDQuark SPIRO2016-09-23
18052400180072COSMEDSpiropalm2016-09-23
18052400180096COSMEDSpiropalm 6MWT2016-09-23
18052400180379COSMEDPony FX MIP/MEP2016-09-23
18052400180157COSMEDK4b22016-09-23
18052400180164COSMEDQuark PFT2016-09-23
18052400180188COSMEDQuark CPET2016-09-23
18052400180225COSMEDFitmate Pro2016-09-23
18052400180249COSMEDFitmate Med2016-09-23
18052400180263COSMEDQuark C12x2016-09-23
18052400180287COSMEDQuark T12x2016-09-23
18052400180355COSMEDQ-Box2016-09-23

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Primary DI, Brand, Company table
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