QDB

Photoplethysmograph Analysis Software For Over-The-Counter Use

Product code: QDB
Device name: Photoplethysmograph Analysis Software For Over-The-Counter Use
Device class: Class 2
21 CFR: 21 CFR 870.2790
Medical specialty: Cardiovascular
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

FDA classification definition

A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QDB

Classification and pathway per current FDA publications. Data from openFDA (CC0).