Electrocardiograph Software For Over-The-Counter Use
QDA · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2345
Classification
FDA Product Code
QDA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.2345
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.