← Product Code [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF) · K851358

# MODEL BION 2/TYPE 90 ROOM IONIZER (K851358)

_Medicor USA , Ltd. · FRF · Jul 1, 1985 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K851358

## Device Facts

- **Applicant:** Medicor USA , Ltd.
- **Product Code:** [FRF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF.md)
- **Decision Date:** Jul 1, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5045
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K851358](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRF/K851358)

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