510(k) K081062
- Device
- AIRSONNETT AIRSHOWER AIR 3
- Applicant
- AIRSONETT, INC.
- 510(k) number
- K081062
- Product code
- FRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-11-07
- Date received
- 2008-04-14
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CONSTANCE G BUNDY
- Address
- 6470 Riverview Ter. Findley MN US 55432 55432
FDA Registration Numbers#
- 3003007759
- 9616085
- 3017406271
- 3000135138
- 3010405299
- 3004793042
- 3004871905
- 3014498814
- 3010238358
- 3026310685
- 3019543795
Source Documents#
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| 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 |
| 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 |
| K012549 | ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM | Healthway Products, Inc. | 2002-02-04 |
Legacy Summary#
summary
FDA Review#
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