← Product Code [FOG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG) · K770754

# DUODENOSCOPE, MOLEL TX-6 (K770754)

_American Cystocope Makers, Inc. · FOG · Apr 28, 1977 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K770754

## Device Facts

- **Applicant:** American Cystocope Makers, Inc.
- **Product Code:** [FOG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG.md)
- **Decision Date:** Apr 28, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5700
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K770754](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FOG/K770754)

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