← Product Code [FME](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME) · K811915

# MONITOR/VITAL SIGNS TRAY (K811915)

_American Hospital Supply Corp. · FME · Jul 28, 1981 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME/K811915

## Device Facts

- **Applicant:** American Hospital Supply Corp.
- **Product Code:** [FME](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME.md)
- **Decision Date:** Jul 28, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6265
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME/K811915](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FME/K811915)

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