Multivariate Vital Signs Index

FDA product code PLB · Class II (moderate risk) · 21 CFR 870.2300 · Cardiovascular

Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.

8510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K240756Aitrics-VcPLB · Traditional Aitrics Co., Ltd.07/23/2024SE
K240558NavoycdsPLB · Traditional Algodx AB07/22/2024SE
K230386SpassageQPLB · Traditional Spass, Inc.06/15/2023SE
K213423T3 Platform softwarePLB · Traditional Etiometry, Inc.01/06/2023SE
K183282Biovitals Analytics EnginePLB · Traditional Biofourmis Singapore Pte., Ltd.08/15/2019SE
K152258T3 SoftwarePLB · Traditional Etiometry, Inc.03/31/2016SE
K142512Personalized Physiology Analytics Engine softwarePLB · Traditional Vgbio, Inc (Dba Physiq)06/11/2015SE
K843905Trauma Care EvaluationPLB · Traditional Quantitative09/26/1985SE