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K Number
K192556
Device Name
Carnation Ambulatory Monitor
Manufacturer
Bardy Diagnostics, Inc
Date Cleared
2019-10-17

(30 days)

Product Code
DSH
Regulation Number
870.2800
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Carnation Ambulatory Monitor and primarily discusses regulatory information and the device's indications for use. It does not include details on formal acceptance criteria, device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications.

§ 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).