FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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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.

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K Number

K001174

Device Name

COSMED QUARK

Manufacturer

COSMED S.R.L.

Date Cleared

2001-01-11

(275 days)

Product Code