21 CFR 870.2675 — Oscillometer
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2675
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRZ | Oscillometer | 2 | 0 |
Special Controls
DRZ — Oscillometer
*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.
eCFR
