← Product Code [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ) · K781591

# NEBULIZER/HUMIDIFIER MODEL EH 147B (K781591)

_Mistogen Equipment Co. · KFZ · Oct 16, 1978 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K781591

## Device Facts

- **Applicant:** Mistogen Equipment Co.
- **Product Code:** [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ.md)
- **Decision Date:** Oct 16, 1978
- **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/K781591](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K781591)

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