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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
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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

AI/ML Overview

This is a 510(k) premarket notification for an electrocardiograph, a device that records the electrical activity of the heart. The provided text doesn't contain information about AI/ML algorithms, performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies. These types of studies and details are typically associated with the evaluation of AI-powered diagnostic tools.

Therefore, I cannot provide the requested information based on the provided document. The document primarily focuses on the regulatory clearance process for a traditional medical device, confirming its substantial equivalence to a predicate device.

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).