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K Number
K130409
Device Name
ALIVECOR HEART MONITOR
Manufacturer
ALIVECOR, INC.
Date Cleared
2013-09-06

(199 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AliveCor Heart Monitor is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to AliveCor, Inc. for their "AliveCor Heart Monitor." This document primarily grants substantial equivalence based on indications for use and general regulatory compliance. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot answer your request based on the provided input. This document is a regulatory approval letter, not a clinical study report or a technical performance evaluation.

§ 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).