21 CFR 892.1820 — Chair, Pneumoencephalographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1820
Identification
A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain).
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 § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HBK | Chair, Pneumoencephalographic | 2 | 0 |
Special Controls
HBK — Chair, Pneumoencephalographic
*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 § 892.9.
eCFR
