510(k) K062716
- Device
- ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
- Applicant
- ECO-RX, INC.
- 510(k) number
- K062716
- Product code
- FRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-27
- Date received
- 2006-09-12
- 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
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- CONSTANCE R BROWN, ESQ.
- Address
- 34 Ave. St. Denis Quebec City, Qc CA G1R-4B6 G1R-4B6
FDA Registration Numbers#
- 3004597845
- 3008156690
- 3003547411
- 3032191707
- 3014498814
- 3010446656
- 3015489159
- 3009522781
- 3015139810
- 3019585201
- 3012983142
- 3014151865
- 3015376465
- 3027534461
- 3030650766
Source Documents#
510(k) summary PDF not indicated by FDA
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| K212644 | Aura Storm | Invictus Lighting | 2022-05-26 |
| K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | 2022-02-17 |
| 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 |
Legacy Summary#
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FDA Review#
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