Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1820](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1820) → HBK — Chair, Pneumoencephalographic

# HBK · Chair, Pneumoencephalographic

_Radiology · 21 CFR 892.1820 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/HBK

## Overview

- **Product Code:** HBK
- **Device Name:** Chair, Pneumoencephalographic
- **Regulation:** [21 CFR 892.1820](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1820)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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.

## 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 § 892.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/HBK](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/HBK)

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