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Electrocardiograph Software For Over-The-Counter Use

FDA product code QDA · 8 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2345
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-08-04 – 2025-06-15

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.

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