PLB
- Product code
- PLB
- Device name
- Multivariate Vital Signs Index
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2300
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240756 | 2024-07-23 | Aitrics Co., Ltd. | AITRICS-VC | |
| K240558 | 2024-07-22 | Algodx AB | NAVOYCDS | FDA |
Official FDA classification page: PLB
Classification and pathway per current FDA publications. Data from openFDA (CC0).