FDA7 Oct 2021 11:40
To those who are part of the FDA conspiracy theory about non-US applications...
Why did they grant this one from an Oxford UK company earlier this year...I note too that this was lodged in Covid times, and granted in Covid times. Overall time to grant it was pretty much exactly a year, which takes us for Angle to roughly where we are now, so nothing unusual about the time taken at Angle to date...
Applicant: Oxehealth Limited, Magdalen Center North, The Oxford Science Park
Oxford, GB Ox4 4ga
Device Classification Name: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
De Novo Number DEN200019
Device Name Oxehealth Vital Signs
Date Received 03/27/2020
Decision Date 03/26/2021
Decision Granted (DENG)
Classification Advisory Committee Cardiovascular