21 CFR § 882.4440 - Neurosurgical headrests.
§ 882.4440 Neurosurgical headrests.
(a) Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.
(b) Classification. 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.