Medical Device Manufacturer · US , Menlo Park , CA

Abbott Electrophysiology - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2016

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Electrophysiology Cardiovascular ✕

4 devices

1-4 of 4

Cleared Sep 01, 2017

RhythmView Workstation

Cardiovascular · 93d

Cleared Feb 28, 2017

FIRMap Catheter

Cardiovascular · 60d

Cleared Aug 10, 2016

Rhythm View Workstation (non-streaming)

Cardiovascular · 100d

Cleared Apr 07, 2016

FIRMap Catheter

Cardiovascular · 164d