← Product Code [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ) · K810335

# RESPIRIZER (K810335)

_Respirizer Co., Div. Campillary Systems, Inc. · KFZ · Mar 20, 1981 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K810335

## Device Facts

- **Applicant:** Respirizer Co., Div. Campillary Systems, Inc.
- **Product Code:** [KFZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ.md)
- **Decision Date:** Mar 20, 1981
- **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/K810335](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/KFZ/K810335)

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