Bluezone Model RX-450 Air Purifier— 510(k) K212824

Name: FDA 510(k) clearance K212824
Creator: U.S. Food and Drug Administration
Published: 2022-02-17

Substantially Equivalent

Bluezone Products, Inc.

FDA 510(k) clearance K212824 for Bluezone Model RX-450 Air Purifier, Substantially Equivalent on 2022-02-17. Applicant: Bluezone Products, Inc.. Device class: 2.

Clearance details

Applicant: Bluezone Products, Inc.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2021-09-03
Decision date: 2022-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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