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K Number
K122356
Device Name
ALIVECOR HEART MONITOR FOR IPHONE
Manufacturer
ALIVECOR, INC.
Date Cleared
2012-11-19

(108 days)

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

The AliveCor Heart Monitor for iPhone 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

This document is a 510(k) premarket notification from the FDA for the AliveCor Heart Monitor for iPhone. It acknowledges the receipt and review of the device and states that it is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a notification of substantial equivalence, not a detailed report of clinical trials or performance metrics.

Therefore, I cannot provide the requested information based on the provided text.

§ 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).