PLB · Multivariate Vital Signs Index
Cardiovascular · 21 CFR 870.2300 · Class 2
Overview
| Product Code | PLB |
|---|---|
| Device Name | Multivariate Vital Signs Index |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240756 | AITRICS-VC | Aitrics Co., Ltd. | Jul 23, 2024 | SESE |
| K240558 | NAVOYCDS | Algodx AB | Jul 22, 2024 | SESE |
| K230386 | SpassageQ | Spass, Inc. | Jun 15, 2023 | SESE |
| K213423 | T3 Platform software | Etiometry, Inc. | Jan 6, 2023 | SESE |
| K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | Aug 15, 2019 | SESE |
| K152258 | T3 Software | Etiometry, Inc. | Mar 31, 2016 | SESE |
| K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | Jun 11, 2015 | SESE |
| K843905 | TRAUMA CARE EVALUATION | Quantitative | Sep 26, 1985 | SESE |
Top Applicants
- Etiometry, Inc. — 2 clearances
- Aitrics Co., Ltd. — 1 clearance
- Algodx AB — 1 clearance
- Biofourmis Singapore Pte., Ltd. — 1 clearance
- Quantitative — 1 clearance
