21 CFR 870.1130 — System, Measurement, Blood-Pressure, Non-Invasive
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1130
Identification
A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 1208 | 3rd Party |
| QYF | Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms) | 2 | 0 | SaMD |
