Carnation Ambulatory Monitor

• K Number: K200870
• Device Name: Carnation Ambulatory Monitor
• Manufacturer: Bardy Diagnostics, Inc
• Date Cleared: 2020-05-01 ( 30 days)
• Product Code: DSH
• Regulation Number: 870.2800
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain detailed information about the acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC study outcomes. The document is an FDA 510(k) clearance letter for the Carnation Ambulatory Monitor, confirming its substantial equivalence to a predicate device. It defines the intended use but does not delve into the specifics of a clinical study or performance evaluation with quantified metrics against acceptance criteria.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).