Cleared Special

Oxehealth Vital Signs

K220899 · Oxehealth Limited · Cardiovascular

Apr 2022

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K220899 is an FDA 510(k) clearance for the Oxehealth Vital Signs, a Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (Class II — Special Controls, product code QME), submitted by Oxehealth Limited (Oxford, GB). The FDA issued a Cleared decision on April 29, 2022, 32 days after receiving the submission on March 28, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2785.

Submission Details

510(k) Number	K220899 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2022
Decision Date	April 29, 2022
Days to Decision	32 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QME — Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2785
Definition	The Device Uses Software Algorithms To Analyze Video Signal And Estimate Pulse Rate, Heart Rate, Respiratory Rate And/or Breathing Rates. This Device Is Not Intended To Independently Direct Therapy.