21 CFR 880.6150 — Cleaner, Ultrasonic, Medical Instrument

General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6150

Identification

An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.

Classification Rationale

Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, 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
FLGCleaner, Ultrasonic, Medical Instrument119
Innolitics

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