21 CFR 882.1240 — Echoencephalograph
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1240
Identification
An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXW | Echoencephalograph | 2 | 7 | 3rd Party |
