Bluezone Model RX-450 Air Purifier

Purifier, Air, Ultraviolet, Medical

Bluezone Products, Inc.

The following data is part of a premarket notification filed by Bluezone Products, Inc. with the FDA for Bluezone Model Rx-450 Air Purifier.

Pre-market Notification Details

Device IDK212824
510k NumberK212824
Device Name:Bluezone Model RX-450 Air Purifier
ClassificationPurifier, Air, Ultraviolet, Medical
Applicant Bluezone Products, Inc. 225 Wildwood Avenue Woburn,  MA  01801
ContactKaren Benedek
CorrespondentMaureen O'connell
O'Connell Regulatory Consultant, Inc. 44 Oak Street Stoneham,  MA  02180
Product CodeFRA  
CFR Regulation Number880.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-03
Decision Date2022-02-17

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