PLB
8 FDA 510(k) clearances · Product code
262 daysmedian time to decision
443 days90th percentile
8clearances measured
FDA profile
- Official device name
- Multivariate Vital Signs Index
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Medical specialty
- Cardiovascular
- FDA definition
- Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AITRICS-VC (K240756) | Aitrics Co., Ltd. | 2024-07-23 |
| NAVOYCDS (K240558) | Algodx AB | 2024-07-22 |
| SpassageQ (K230386) | Spass, Inc. | 2023-06-15 |
| T3 Platform software (K213423) | Etiometry, Inc. | 2023-01-06 |
| Biovitals Analytics Engine (K183282) | Biofourmis Singapore Pte., Ltd. | 2019-08-15 |
| T3 Software (K152258) | Etiometry, Inc. | 2016-03-31 |
| Personalized Physiology Analytics Engine software (K142512) | Vgbio, Inc (Dba Physiq) | 2015-06-11 |
| TRAUMA CARE EVALUATION (K843905) | Quantitative | 1985-09-26 |
Track PLB automatically
Every clearance here is in the API, with alerts when new ones post.