510(k) K012549
- Device
- ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
- Applicant
- HEALTHWAY PRODUCTS, INC.
- 510(k) number
- K012549
- Product code
- FRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-04
- Date received
- 2001-08-07
- Regulation
- 880.5045
- Classification name
- Cleaner, Air, Medical Recirculating
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DICK BRIGGS
- Address
- P.O. Box 2729 Syracuse NY US 13220 13220
FDA Registration Numbers#
- 3003007759
- 9616085
- 3017406271
- 3000135138
- 3010405299
- 3004793042
- 3004871905
- 3014498814
- 3010238358
- 3026310685
- 3019543795
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FRF #
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|---|---|---|---|
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited | 2025-11-14 |
| K242102 | CerroZone Mini | Cerrozone, LLC | 2024-11-19 |
| K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | 2024-06-14 |
| K223835 | MA-40, MA-112 | Medify Air, LLC | 2023-09-18 |
| K222416 | RIA Safeguard | Ria Tech Co., Ltd. | 2023-05-01 |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) | Beiang Air Tech , Ltd. | 2022-11-22 |
| K220990 | Qorda QD1 | Winix, Inc. | 2022-09-14 |
| K220298 | CerroZone Mobile | Cerrozone | 2022-07-01 |
| K200321 | Novaerus NV1050 | Novaerus Us, Inc. | 2020-12-28 |
| K130702 | AIRSONETT AIR-4 | Airsonett AB | 2013-07-23 |
| K112728 | HEPAIRX VENTILATING AIR PURIFIER | Air Innovations, Inc. | 2013-01-23 |
| K081062 | AIRSONNETT AIRSHOWER AIR 3 | Airsonett, Inc. | 2008-11-07 |
| K072185 | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 | Airistar Technologies, LLC | 2008-03-27 |
| K070722 | PLASMAIR, MODEL T2006 | Airinspace B.V. | 2007-12-14 |
| K023693 | MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100 | Airex, Inc. | 2003-03-12 |
Legacy Summary#
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FDA Review#
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