FDA 510(k) · AliveCor
K130921: ALIVECOR HEART MONITOR OTC (AliveCor, Inc.)
AliveCor, Inc. received FDA 510(k) K130921 for ALIVECOR HEART MONITOR OTC, with a decision date of Feb 6, 2014 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K130921 |
|---|---|
| Pathway | 510(k) |
| Applicant | AliveCor, Inc. |
| Device name | ALIVECOR HEART MONITOR OTC |
| Product code | DPS: Electrocardiograph |
| Regulation (21 CFR) | 870.2340 |
| Device class | Class 2 |
| Date received | Apr 3, 2013 |
| Decision date | Feb 6, 2014 |
| 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: __________ Device Names:* AliveCor Heart Monitor indications for Use: The AliveCor Heart Monitor is intended to record, display (when prescribed or used under the care of a physician), store and transfer single-channel electrocardiogram (ECG) rhythms. Prescription Use X Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (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) . . -V- ,igned by s ~%Q/Rjf'Faris -S 30 Maiden Lane, 6d' Floor San Francisco, CA 94108 1 415.795.9804 Iwww.allvecor.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.
Later records that cite K130921
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.