Who else makes this device?

Name: Cortex Cpet System
Brand: Cortex Cpet System

Anesthesiology › DiagnosticCalculator, Predicted Values, Pulmonary Function

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.

Chinese manufacturers registered for FDA product code BTY
Manufacturer	City	Province	Registered as	Device types
Guangzhou Homesun Medical Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	4

Record

Regulatory record for Cortex Cpet System
Listed by	Cortex Biophysik Gmbh, Germany
FDA product code	BTY
Device type	Calculator, Predicted Values, Pulmonary Function
Device class	Class 2
Regulation	21 CFR 868.1890
Establishment	Manufacturer
510(k)	K993641
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
MetaLyzer3B		In distribution

Same Product Code

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Cosmed	C O S M E D SRL	8
MasterScope	eResearchTechnology GmbH	7
Shape-HF	Shape Medical Systems, Inc	3
Avea	Vyaire Medical, Inc.	3
Pneumotach	eResearchTechnology GmbH	2
ERT PT	eResearchTechnology GmbH	2
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Showing 12 of 28. All products under Calculator, Predicted Values, Pulmonary Function

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K993641	2000-12-14

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.