21 CFR 880.6320 — Device, Medical Examination, Ac Powered
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6320
Identification
An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
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 § 880.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KZF | Device, Medical Examination, Ac Powered | 1 | 37 | |
| PEQ | Accessories To Examination Light | 1 | 1 |