← Product Code [BZE](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE) · K761295

# RESP. AIR TEMP. CONTROL & HAZARD MON. (K761295)

_Harris-Lake, Inc. · BZE · Dec 30, 1976 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K761295

## Device Facts

- **Applicant:** Harris-Lake, Inc.
- **Product Code:** [BZE](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE.md)
- **Decision Date:** Dec 30, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5270
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K761295](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K761295)

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