← Product Code [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ) · K760341

# HUMIDIFIER, ELECTRONIC (EH147) (K760341)

_Mistogen Equipment Co. · KFZ · Aug 11, 1976 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K760341

## Device Facts

- **Applicant:** Mistogen Equipment Co.
- **Product Code:** [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ.md)
- **Decision Date:** Aug 11, 1976
- **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/K760341](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K760341)

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