HBN · Chair, Neurosurgical
Neurology · 21 CFR 882.4125 · Class 1
Overview
| Product Code | HBN |
|---|---|
| Device Name | Chair, Neurosurgical |
| Regulation | 21 CFR 882.4125 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery.
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 § 882.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | Skytron, Div. the Kmw Group, Inc. | Sep 4, 1990 | SESE |
| K822428 | SURGI-QUIP MICROSCOPE STAND | Surgi-Quip Inc.U | Sep 2, 1982 | SESE |
| K822426 | MCINTYRE MICROSCOPE STAND | Surgi-Quip Inc.U | Sep 2, 1982 | SESE |
| K822012 | BINOCULAR OPERATING MICROSCOPES & | Kelleher Corp. | Jul 30, 1982 | SESE |
Top Applicants
- Surgi-Quip Inc.U — 2 clearances
- Kelleher Corp. — 1 clearance
- Skytron, Div. the Kmw Group, Inc. — 1 clearance
