← Product Code [CAN](/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN) · K901623

# AMBU OXYGEN REGULATOR (K901623)

_Flotec, Inc. · CAN · Apr 26, 1990 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K901623

## Device Facts

- **Applicant:** Flotec, Inc.
- **Product Code:** [CAN](/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN.md)
- **Decision Date:** Apr 26, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2700
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K901623](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K901623)

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