21 CFR 882.4440 — Headrest, Neurosurgical
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4440
Identification
A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HBM | Headrest, Neurosurgical | 1 | 3 |
