FDA 510(k) · Medicalgorithmics
K112921: MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM (Medicalgorithmics S.A.)
Medicalgorithmics S.A. received FDA 510(k) K112921 for MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM, with a decision date of May 16, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K112921 |
|---|---|
| Pathway | 510(k) |
| Applicant | Medicalgorithmics S.A. |
| Device name | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM |
| Product code | DSI: Detector And Alarm, Arrhythmia |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Oct 3, 2011 |
| Decision date | May 16, 2012 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Abbreviated |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
and contradictions The indications for use for the PocketECi v2 monitor are as follows:
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.
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 DSI is "Detector And Alarm, Arrhythmia", class 2, 21 CFR 870.1025.
Our labels for filtering: claim AFib / irregular rhythm, sensor ECG electrodes. These are heuristics, not FDA fields.