FDA 510(k) · AliveCor
K142743: AliveCor Heart Monitor (AliveCor, Inc.)
AliveCor, Inc. received FDA 510(k) K142743 for AliveCor Heart Monitor, with a decision date of Jan 27, 2015 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K142743 |
|---|---|
| Pathway | 510(k) |
| Applicant | AliveCor, Inc. |
| Device name | AliveCor Heart Monitor |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Sep 24, 2014 |
| Decision date | Jan 27, 2015 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
STATEMENT 510(k) Number (if known): K142743 Device Name: AliveCor Heart Monitor Indications For Use: 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). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and it is not intended for pediatric use. Prescription Use X And/Or Over the Counter Use __ X __ (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 3DJHRI ALIVECOR, INC. K142743 ALIVECOR HEART MONITOR TRADITIONAL 510(k) PREMARKET NOTIFICATION 510(K) SUMMARY 510(k) Premarket Notification: K142743 GENERAL INFORMATION Applicant: AliveCor, Inc. 30 Maiden Lane, 6th Floor San Francisco, CA 94108 Contact Person: Albert Boniske Director of Regulatory Affairs AliveCor, Inc. Phone: 415-795-9811 Fax: 415-397-0440 Date Prepared: September 22, 2014 DEVICE INFORMATION Trade Name: AliveCor Heart Monitor Generic/Common Name: Telephone electrocardiograph transmitter and receiver Classification: 21 CFR§870.2920, Transmitters and Receivers, Electrocardiograph, Telephone, Class II Product Code: DXH, DPS
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K140933 ALIVECOR HEART MONITOR (AliveCor)
Later records that cite K142743
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.