PLB — Multivariate Vital Signs Index Class II
Classification Details
- Product Code
- PLB
- Device Class
- Class II
- Regulation Number
- 870.2300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240756 | aitrics co | AITRICS-VC | July 23, 2024 |
| K240558 | algodx | NAVOYCDS | July 22, 2024 |
| K230386 | spass | SpassageQ | June 15, 2023 |
| K213423 | etiometry | T3 Platform software | January 6, 2023 |
| K183282 | biofourmis singapore pte | Biovitals Analytics Engine | August 15, 2019 |
| K152258 | etiometry | T3 Software | March 31, 2016 |
| K142512 | vgbio, inc (dba physiq) | Personalized Physiology Analytics Engine software | June 11, 2015 |
| K843905 | quantitative | TRAUMA CARE EVALUATION | September 26, 1985 |