DRZ · Oscillometer
Cardiovascular · 21 CFR 870.2675 · Class 2
Overview
| Product Code | DRZ |
|---|---|
| Device Name | Oscillometer |
| Regulation | 21 CFR 870.2675 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
