21 CFR 870.2300 — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2300
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 338 | 3rd Party |
| MSX | System, Network And Communication, Physiological Monitors | 2 | 117 | Life-Sustaining |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 304 | 3rd Party |
| PFY | Low Patient Acuity Monitoring System | 2 | 0 | SaMD |
| PLB | Multivariate Vital Signs Index | 2 | 8 | SaMD |
