Airsonnett Airshower Air 3

FDA 510(k) K081062 · Airsonett, Inc.

Substantially Equivalent

510(k) numberK081062

Submission

Device name
Airsonnett Airshower Air 3
Applicant
Airsonett, Inc.
Findley, MN, US
Received
April 14, 2008
Decision date
November 7, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRF – Cleaner, Air, Medical Recirculating
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5045
Specialty
General Hospital

Other 510(k)s with product code FRF

510(k)DeviceApplicantDecision
K251872Biomoneta Avata RxFRF · Traditional Biomoneta Research Private Limited11/14/2025SE
K242102CerroZone MiniFRF · Traditional Cerrozone, LLC11/19/2024SE
K240696Airdog X8 Air Purifier (KJ800F-X8)FRF · Special Suzhou Beiang Smart Technology Co., Ltd.06/14/2024SE
K223835MA-40, MA-112FRF · Traditional Medify Air, LLC09/18/2023SE
K222416RIA SafeguardFRF · Traditional Ria Tech Co., Ltd.05/01/2023SE
K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)FRF · Traditional Beiang Air Tech , Ltd.11/22/2022SE
K220990Qorda QD1FRF · Traditional Winix, Inc.09/14/2022SE
K220298CerroZone MobileFRF · Traditional Cerrozone07/01/2022SE
K200321Novaerus NV1050FRF · Traditional Novaerus Us, Inc.12/28/2020SE
K130702Airsonett AIR-4FRF · Traditional Airsonett AB07/23/2013SE

More from Airsonett AB

510(k)DeviceDecision
K130702Airsonett AIR-4FRF · Traditional 07/23/2013SE

Questions and answers

When was Airsonnett Airshower Air 3 cleared by the FDA?

Airsonnett Airshower Air 3 (K081062) received a 510(k) decision of Substantially Equivalent on November 7, 2008, 207 days after the submission was received.

What is the product code of K081062?

The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.