← Product Code [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ) · K862042

# SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (K862042)

_Associated Mills, Inc. · KFZ · Jun 5, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K862042

## Device Facts

- **Applicant:** Associated Mills, Inc.
- **Product Code:** [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ.md)
- **Decision Date:** Jun 5, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5460
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K862042](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K862042)

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