K232804 is an FDA 510(k) clearance for the FibriCheck. 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 Qompium NV (Hasselt, BE). The FDA issued a Cleared decision on June 7, 2024, 269 days after receiving the submission on September 12, 2023.
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 | K232804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2023 |
| Decision Date | June 07, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| 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. |