Multivariate Vital Signs Index
The Multivariate Vital Signs Index (product code PLB) is a Class 2 cardiovascular device that performs automated calculation of a summary index or indices based on multiple individual measured vital sign inputs, regulated under 870.2300. It requires 510(k) clearance and falls within the cardiovascular medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PLB
- Device Class
- FDA class 2
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240756 | AITRICS-VC | Jul 23, 2024 | Substantially Equivalent | Aitrics Co., Ltd. |
| K240558 | NAVOYCDS | Jul 22, 2024 | Substantially Equivalent | Algodx AB |
| K230386 | SpassageQ | Jun 15, 2023 | Substantially Equivalent | Spass, Inc. |
| K213423 | T3 Platform software | Jan 06, 2023 | Substantially Equivalent | Etiometry, Inc. |
| K183282 | Biovitals Analytics Engine | Aug 15, 2019 | Substantially Equivalent | Biofourmis Singapore Pte., Ltd. |
| K152258 | T3 Software | Mar 31, 2016 | Substantially Equivalent | Etiometry, Inc. |
| K142512 | Personalized Physiology Analytics Engine software | Jun 11, 2015 | Substantially Equivalent | Vgbio, Inc (Dba Physiq) |
| K843905 | TRAUMA CARE EVALUATION | Sep 26, 1985 | Substantially Equivalent | Quantitative |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.