510(k) K212824
- Device
- Bluezone Model RX-450 Air Purifier
- Applicant
- Bluezone Products, Inc.
- 510(k) number
- K212824
- Product code
- FRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-17
- Date received
- 2021-09-03
- Regulation
- 880.6500
- Classification name
- Purifier, Air, Ultraviolet, Medical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Karen Benedek
- Address
- 225 Wildwood Ave. Woburn MA US 01801 01801
FDA Registration Numbers#
- 3008156690
- 3044735899
- 3015489159
- 3015139810
- 3019585201
- 3009522781
- 3003547411
- 3004597845
- 3014498814
- 3015376465
- 3032191707
- 3030650766
- 3010446656
- 3012983142
- 3014151865
- 3027534461
Source Documents#
Other 510(k) Records For Product Code FRA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252128 | Zener® (model ZEN-001-B1) | Uvx, Inc. | 2025-09-15 |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC | 2024-08-01 |
| K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | 2024-05-23 |
| K232933 | AirKEE P900 | Healkee Medical Pte, Ltd. | 2024-05-16 |
| K232645 | Airgle Room Air Purifier | Airgle Corporation | 2024-02-16 |
| K221540 | Synexis Sphere Rx | Synexis, LLC | 2023-06-14 |
| K222702 | RGS; RGS Mini | Genesis Air, Inc. | 2023-06-02 |
| K223328 | Purgo | Aeroclean Technologies, Inc. | 2022-11-30 |
| K213753 | Purgo | Aeroclean Technologies, LLC | 2022-06-01 |
| K212644 | Aura Storm | Invictus Lighting | 2022-05-26 |
| K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | 2021-11-26 |
| K211194 | Molekule Air Pro | Molekule, Inc. | 2021-08-20 |
| K202766 | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. | 2021-06-11 |
| K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021-02-23 |
| K203189 | AEROCURE-MD | Aerobiotix, Inc. | 2021-01-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases