Definition: For Non-continuous Central Monitoring Of Patient Parameters, Including Cardiac Parameters, In Low Risk Patients.
| Device Type ID | 964 |
| Device Name | Low Patient Acuity Monitoring System |
| Physical State | Electronic Software-driven Monitor |
| Technical Method | Electronic Display At A Central Monitoring Station Of Monitoring Data From Patient Sensors. |
| Target Area | Involves Cardiac Sensing And Other Sensor Locations On The Body |
| 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 | PFY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 964 |
| Device | Low Patient Acuity Monitoring System |
| Product Code | PFY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiac Monitor (including Cardiotachometer And Rate Alarm). |
| CFR Regulation Number | 870.2300 [🔎] |