De Novo DEN180044

Device: ECG App
Contact: donna-bea tillman
De Novo number: DEN180044
Product code: QDA
Regulation: 870.2345
Classification name: electrocardiograph software for over-the-counter use
Decision: granted (DENG)
Decision date: 2018-09-11
Date received: 2018-08-14
Classification advisory: Cardiovascular
Review advisory: Cardiovascular
Type: Direct

Current FDA Classification#

Product code: QDA
Device name: Electrocardiograph Software For Over-The-Counter Use
Medical specialty: Cardiovascular
Device class: 2
Regulation: 870.2345
Implant: N
Life sustain/support: N