21 CFR 882.1925 — Block, Test, Ultrasonic Scanner Calibration
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1925
Identification
An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXX | Block, Test, Ultrasonic Scanner Calibration | 1 | 3 |
