FDA 510(k) Applications for Medical Device:
Purifier, Air, Ultraviolet, Medical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K052732 | ABRACAIR, INC. |
801 BARRET AVENUE | LOUSVILLE | KY | 40204 |
| K203189 | Aerobiotix, Inc. |
444 Alexandersville Rd. | Miamisburg | OH | 45342 |
| K223328 | AeroClean Technologies, Inc. |
10455 Riverside Drive, Ste. 100 | Palm Beach Gardens | FL | 33410 |
| K213753 | AeroClean Technologies, LLC |
10455 Riverside Drive, Ste. 100 | Palm Beach Gardens | FL | 33410 |
| K201220 | Aerus Medical LLC |
14841 Dallas Parkway, | Dallas | TX | 75254 |
| K972064 | BIOLOGICAL CONTROLS, INC. |
ONE INDUSTRIAL WAY WEST | EATONTOWN | NJ | 07724 |
| K212824 | Bluezone Products, Inc. |
225 Wildwood Avenue | Woburn | MA | 01801 |
| K062716 | ECO-RX, INC. |
34 AVENUE ST. DENIS | QUEBEC CITY, QC | G1R-4B6 | |
| K222702 | Genesis Air, Inc. |
5202 County Road 7350, Suite D | Lubbock | TX | 79424 |
| K202766 | Guangzhou Ajax Medical Equipment Co., Ltd. |
Building No 2 Dagang industrial zone, Shilou Town,Panyu, | Guangzhou | 511447 | |
| K133800 | HGI INDUSTIRES |
2055 HIGH RIDGE ROAD | BOYNTON BEACH | FL | 33426 |
| K212644 | Invictus Lighting |
1401 Main Ave. SW | Hickory | NC | 28602 |
| K033448 | JOHN MFG., LTD. |
18780 AMAR ROAD, STE 203-203 | WALNUT | CA | 91789 |
| K023830 | KES SCIENCE & TECHNOLOGY, INC |
3625 KENNESAW N.INDUSTRIAL PKY | KENNESAW | GA | 30144 |
| K202339 | Molekule, Inc. |
1301 Folsom St. | San Francisco | CA | 94103 |
| K211194 | Molekule, Inc. |
1301 Folsom St. | San Francisco | CA | 94103 |
| K200500 | Molekule, Inc. |
1301 Folsom St. | San Francisco | CA | 94103 |
| K980745 | MONAGAN ENT., INC. |
14247 RIDGE RD. | ALBION | NY | 14411 |
| K211139 | Samsung Electronics Co., Ltd. |
129, Samsung-Ro, Yeongtong-Gu | Suwon-Si | 16677 | |
| K954448 | SCHIFF & CO. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K221540 | Synexis, LLC |
11711 W. 79th Street | Lenexa | KS | 66214 |
| K161468 | Transformair, LLC |
3802 Spectrum Blvd Suite 143 | Tampa | FL | 33612 |
| K960833 | UV TECHNOLOGIES, INC. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
