PLB

Multivariate Vital Signs Index

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-07-23.

NumberDecision dateApplicantDevice nameSummary
K2407562024-07-23Aitrics Co., Ltd.AITRICS-VCPDF
K2405582024-07-22Algodx ABNAVOYCDSFDA

1 summaries are archived here for direct download.

Official FDA classification page: PLB
Classification and pathway per current FDA publications. Data from openFDA (CC0).