Medical Device Manufacturer · CH , Lausanne

Smartcardia SA

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied

Smartcardia SA — FDA 510(k) Submissions

Smartcardia SA has submitted 2 FDA 510(k) premarket notifications since 2023, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Detector And Alarm, Arrhythmia, Outpatient Cardiac Telemetry . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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All2 Cardiovascular 2