FDA 510(k) Applications for Medical Device Product Code "FRF"
(Cleaner, Air, Medical Recirculating)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K984116 | ABATEMENT TECHNOLOGIES, INC. | HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C | 06/24/1999 |
| K112728 | AIR INNOVATIONS, INC. | HEPAIRX VENTILATING AIR PURIFIER | 01/23/2013 |
| K023693 | AIREX INC. | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | 03/12/2003 |
| K070722 | AIRINSPACE B.V. | PLASMAIR, MODEL T2006 | 12/14/2007 |
| K072185 | AIRISTAR TECHNOLOGIES, LLC | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | 03/27/2008 |
| K130702 | AIRSONETT, AB | AIRSONETT AIR-4 | 07/23/2013 |
| K081062 | AIRSONETT, INC. | AIRSONNETT AIRSHOWER AIR 3 | 11/07/2008 |
| K211507 | Beiang Air Tech LTD. | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | 11/22/2022 |
| K974682 | BIOLOGICAL CONTROLS, INC. | MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP | 01/23/1998 |
| K220298 | CerroZone | CerroZone Mobile | 07/01/2022 |
| K012549 | HEALTHWAY PRODUCTS, INC. | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | 02/04/2002 |
| K002692 | HMI INDUSTRIES, INC. | DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A | 11/17/2000 |
| K010616 | HMI INDUSTRIES, INC. | DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A | 03/28/2001 |
| K223835 | Medify Air LLC | MA-40, MA-112 | 09/18/2023 |
| K200321 | Novaerus US Inc | Novaerus NV1050 | 12/28/2020 |
| K981841 | RESPIRAID LTD. | BREATHE EASY, MODELS AD AND CD | 10/13/1998 |
| K222416 | RIA Tech Co., Ltd. | RIA Safeguard | 05/01/2023 |
| K960966 | SUNBEAM-OSTER HOUSEHOLD PRODUCTS | HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 | 01/10/1997 |
| K220990 | Winix Inc. | Qorda QD1 | 09/14/2022 |
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