ALIVECOR HEART MONITOR— 510(k) K140933

Substantially Equivalent

AliveCor, Inc.

FDA 510(k) clearance K140933 for ALIVECOR HEART MONITOR, Substantially Equivalent on 2014-08-15. Applicant: AliveCor, Inc.. Device class: 2.

Clearance details

Applicant: AliveCor, Inc.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2014-04-11
Decision date: 2014-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from AliveCor, Inc.

Recalls naming K140933

K-number listed on FDA's recall record

Z-1125-2015 — Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).Class III·Terminated·Alivecor SFO·20150109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140933.

Data sourced from openFDA. This site is unofficial and independent of the FDA.