---
kind: "section"
citation: "21 C.F.R. § 880.6150"
title: "21"
number: "880.6150"
heading: "Ultrasonic cleaner for medical instruments."
url: "https://uscodex.org/cfr/21/880.6150"
---

# §880.6150. Ultrasonic cleaner for medical instruments.

- (a) **Identification.** An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.
- (b) **Classification.** 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](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 880.9](/cfr/21/880.9.md).

## Notes

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.

### Amendments

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]