FDA 510(k) · AliveCor
K122356: ALIVECOR HEART MONITOR FOR IPHONE (AliveCor, Inc.)
AliveCor, Inc. received FDA 510(k) K122356 for ALIVECOR HEART MONITOR FOR IPHONE, with a decision date of Nov 19, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K122356 |
|---|---|
| Pathway | 510(k) |
| Applicant | AliveCor, Inc. |
| Device name | ALIVECOR HEART MONITOR FOR IPHONE |
| Product code | DPS: Electrocardiograph |
| Regulation (21 CFR) | 870.2340 |
| Device class | Class 2 |
| Date received | Aug 3, 2012 |
| Decision date | Nov 19, 2012 |
| 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: i4 2 369 Device Names: AliveCor Heart Monitor for iPhone Indications for Use: The AliveCor H-eart Monitor for iPhone is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms. Prescription Use X Over-The-Counter Use ____ (Part 21 CFR 801 Subpart D) AND/OR1 (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 7 Owen P. Faris -S - *- 2012.11.19 16:09:42 -05'OO' 140 Geary Street, Suite 500 ISan Francisco, CA 94108 415.347.2204 Iwww.alivecor.com
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
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 DPS is "Electrocardiograph", class 2, 21 CFR 870.2340.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.