Cortex Cpet System

The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic Rate Tests for the purpose to objectify the ventilatory, cardio-circulatory and metabolic…

Registry build 21.09.26

The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic Rate Tests for the purpose to objectify the ventilatory, cardio-circulatory and metabolic capacity. With the following indications, they support the user in finding or confirming diagnoses, determining therapy programs and monitoring therapies. In a CPET test, a patient undergoes a period of defined physical stress (normally 10-20 minutes). Hereby data is measured about ventilation, gas exchange and heart rate. On basis of these measured data, further data is calculated and displayed, in order to depict the performance of the cardio-respiratory system. In a spirometry test, the patient performs defined breathing maneuvers (VC, FVC, MVV). Thereby measurement data of the respiratory strength and volume is collected and displayed, in order to show the mechanical capacity of the respiratory system. In a Basal-/Resting Metabolic Rate Test the patient performs a rest test (normally 15-20 minutes). Thereby measurement data of the gas exchange is collected and displayed, in order to estimate the Basal-/Resting Metabolic Rate.

1manufacturer
1catalogue number
1510(k) clearance

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BZC
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77

Record

Regulatory record for Cortex Cpet system
Listed by Cortex Biophysik Gmbh, Germany
FDA product code BZC
Device type Calculator, Pulmonary Function Data
Device class Class 2
Regulation 21 CFR 868.1880
Establishment Manufacturer
510(k) K001631
Record published 2020-09-24

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Cortex Cpet system
Catalogue number Size Status
MetaMax3B In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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APS-Pro SA Jaeger Medical GmbH 3
MGC Diagnostics Medical Graphics Corp. 2
TransAir3 Medi Soft SA 1
MasterScreen PFT Jaeger Medical GmbH 1
Respiratory Mechanics Sensor → Neonatal Draeger Medical Systems, Inc. 1
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Showing 12 of 19. All products under Calculator, Pulmonary Function Data

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K001631 2001-02-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer