Medical Device Manufacturer · US , Westbrook , CT

Pulsion Medical Systems SE

4 submissions · 4 cleared · Since 2012
4
Total
4
Cleared
0
Denied

Pulsion Medical Systems SE — FDA 510(k) Submissions

Pulsion Medical Systems SE has submitted 4 FDA 510(k) premarket notifications since 2012, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Pre-programmed, Single-function, Probe, Thermodilution . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
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All4 Cardiovascular 4