FDA 510(k) · AliveCor
K183319: Triangle System (AliveCor, Inc.)
AliveCor, Inc. received FDA 510(k) K183319 for Triangle System, with a decision date of May 10, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K183319 |
|---|---|
| Pathway | 510(k) |
| Applicant | AliveCor, Inc. |
| Device name | Triangle System |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Nov 30, 2018 |
| Decision date | May 10, 2019 |
| 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
The Triangle System is intended to record, store and transfer one- and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead -I. In two channel mode, the Triangle System can record Lead I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of nonnal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The Triangle System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious ind ivid uals. The device has not been tested and is not intended for pediatr·ic use.
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.
Later records that cite K183319
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.