Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
FDA 510(k) K211507 · Beiang Air Tech , Ltd.
510(k) numberK211507
Submission
- Device name
- Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
- Applicant
- Beiang Air Tech , Ltd.
Suzhou, CN - Received
- May 14, 2021
- Decision date
- November 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRF – Cleaner, Air, Medical Recirculating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5045
- Specialty
- General Hospital
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| K242102 | CerroZone MiniFRF · Traditional | Cerrozone, LLC | 11/19/2024SE |
| K240696 | Airdog X8 Air Purifier (KJ800F-X8)FRF · Special | Suzhou Beiang Smart Technology Co., Ltd. | 06/14/2024SE |
| K223835 | MA-40, MA-112FRF · Traditional | Medify Air, LLC | 09/18/2023SE |
| K222416 | RIA SafeguardFRF · Traditional | Ria Tech Co., Ltd. | 05/01/2023SE |
| K220990 | Qorda QD1FRF · Traditional | Winix, Inc. | 09/14/2022SE |
| K220298 | CerroZone MobileFRF · Traditional | Cerrozone | 07/01/2022SE |
| K200321 | Novaerus NV1050FRF · Traditional | Novaerus Us, Inc. | 12/28/2020SE |
| K130702 | Airsonett AIR-4FRF · Traditional | Airsonett AB | 07/23/2013SE |
| K112728 | Hepairx Ventilating Air PurifierFRF · Traditional | Air Innovations, Inc. | 01/23/2013SE |
Questions and answers
When was Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) cleared by the FDA?
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (K211507) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 557 days after the submission was received.
What is the product code of K211507?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.