BRX · Stool, Anesthesia
Anesthesiology · 21 CFR 868.6700 · Class 1
Overview
| Product Code | BRX |
|---|---|
| Device Name | Stool, Anesthesia |
| Regulation | 21 CFR 868.6700 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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 | RED DOT 2515 CARDIAC SENSOR SYSTEM | 3M Health Care, Ltd. | Dec 23, 1992 | SESE |
Top Applicants
- 3M Health Care, Ltd. — 1 clearance
