← Product Code [LGN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGN) · K790658

# AIRCRAFT TRANSIT ISOLATOR MODEL 121 (K790658)

_Vickers America Medical Corp. · LGN · Jul 3, 1979 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGN/K790658

## Device Facts

- **Applicant:** Vickers America Medical Corp.
- **Product Code:** [LGN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGN.md)
- **Decision Date:** Jul 3, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5450
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGN/K790658](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LGN/K790658)

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