← Product Code [FRF](/productcode/FRF) · K960966

# HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 (K960966)

_Sunbeam-Oster Household Products · FRF · Jan 10, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K960966

## Device Facts

- **Applicant:** Sunbeam-Oster Household Products
- **Product Code:** [FRF](/productcode/FRF.md)
- **Decision Date:** Jan 10, 1997
- **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-staging.innolitics.com/device/K960966](https://fda-staging.innolitics.com/device/K960966)

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