510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PLBClass II

Multivariate Vital Signs Index

21 CFR 870.2300 / Cardiovascular
FDA source (opens on fda.gov)

PLB is the FDA product code for Multivariate Vital Signs Index, a class II device type, regulated under 21 CFR 870.2300. FDA's definition for this code reads: "Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PLB
Device name
Multivariate Vital Signs Index
FDA definition
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code PLB

By decision year
8 clearances under product code PLB with a decision year between 1985 and 2024, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PLB by decision year
YearClearances
19851
20151
20161
20191
20232
20242

Applicants with the most clearances

Product code PLB
Applicants holding the most 510(k) clearances under product code PLB
ApplicantClearances
Etiometry Inc.2
Aitrics Co., Ltd.1
Algodx AB1
Biofourmis Singapore Pte., Ltd.1
Quantitative1
Spass, Inc.1
Vgbio, Inc (dba Physiq)1

Companies listing this code with FDA

Companies whose registered establishments list this code