510(k) K254169 ยท QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
SmartSpectra Vital Signs Monitor 1.0
| Applicant | Presage Security, Inc. d/b/a Presage Technologies, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254169
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.