← Product Code [BZE](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE) · K851245

# ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY (K851245)

_Applinc · BZE · May 15, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K851245

## Device Facts

- **Applicant:** Applinc
- **Product Code:** [BZE](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE.md)
- **Decision Date:** May 15, 1985
- **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/K851245](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZE/K851245)

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