K211906 is an FDA 510(k) clearance for the Vital Signs. This device is classified as 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 July 20, 2021, 29 days after receiving the submission on June 21, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2785. 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..
| 510(k) Number | K211906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | July 20, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| 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. |