Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart G — Miscellaneous](/submissions/AN/subpart-g%E2%80%94miscellaneous) → [21 CFR 868.6700](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6700) → BRX — Stool, Anesthesia

# BRX · Stool, Anesthesia

_Anesthesiology · 21 CFR 868.6700 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BRX

## Overview

- **Product Code:** BRX
- **Device Name:** Stool, Anesthesia
- **Regulation:** [21 CFR 868.6700](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6700)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

An anesthesia stool is a device intended for use as a stool for the anesthesiologist in the operating room.

## 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 § 868.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K924487](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BRX/K924487.md) | RED DOT 2515 CARDIAC SENSOR SYSTEM | 3M Health Care, Ltd. | Dec 23, 1992 | SESE |

## Top Applicants

- 3M Health Care, Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BRX](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BRX)

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