Definition: Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.
| Device Type ID | 968 |
| Device Name | Multivariate Vital Signs Index |
| Physical State | Software/firmware |
| Technical Method | Collects Measured Parameter Inputs And Automates The Calculation Of A Summary Index Based On Those Parameters |
| Target Area | Various |
| Regulation Description | Cardiac Monitor (including Cardiotachometer And Rate Alarm). |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 968 |
| Device | Multivariate Vital Signs Index |
| Product Code | PLB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiac Monitor (including Cardiotachometer And Rate Alarm). |
| CFR Regulation Number | 870.2300 [🔎] |