2 devices · 2 companies · 2015 to 2019
Product code PLB: Multivariate Vital Signs Index
2 devices under product code PLB, 2015 to 2019, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Multivariate Vital Signs Index. 21 CFR 870.2300, Class II. Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Biovitals Analytics EngineK183282 · 510(k) | Biofourmis Singapore Pte. Ltd | Cardiovascular | database entry | |
| Personalized Physiology Analytics Engine softwarK142512 · 510(k) | VGBio, Inc (DBA PhysIQ) | Cardiovascular | database entry |
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