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 CodeDevice NameClassDevicesAttributes
KZFDevice, Medical Examination, Ac Powered137
PEQAccessories To Examination Light11
Innolitics

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