Definition: The Adjunctive Cardiovascular Status Indicator Is A Prescription Device Based On Sensor Technology For The Measurement Of A Physical Parameter(s). This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Inform
| Device Type ID | 978 |
| Device Name | Adjunctive Cardiovascular Status Indicator |
| Physical State | Software/Firmware |
| Technical Method | The Physiological Status Indicator Matches Subject Waveforms To Known Waveforms In An Attempt To Provide A Comprehensive Measure Of All The Changes That Are In The PPG Waveform. The Major Assumption Is That Central Blood Volume, Or More Specifically |
| Target Area | Various |
| Regulation Description | Adjunctive Cardiovascular Status Indicator. |
| 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 | 870.2200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PPW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 978 |
| Device | Adjunctive Cardiovascular Status Indicator |
| Product Code | PPW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Adjunctive Cardiovascular Status Indicator. |
| CFR Regulation Number | 870.2200 [🔎] |