Model Bion 1/TYPE 1084T Car Ionizer
FDA 510(k) K851094 · Medicor USA , Ltd.
510(k) numberK851094
Submission
- Device name
- Model Bion 1/TYPE 1084T Car Ionizer
- Applicant
- Medicor USA , Ltd.
Columbus, OH, US - Received
- March 19, 1985
- Decision date
- June 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K251872 | Biomoneta Avata RxFRF · Traditional | Biomoneta Research Private Limited | 11/14/2025SE |
| 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 |
| K211507 | Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)FRF · Traditional | Beiang Air Tech , Ltd. | 11/22/2022SE |
| 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 |
More from Airsonett AB
| 510(k) | Device | Decision |
|---|---|---|
| K861994 | Model RS-3I Radiographic/Fluroscopic X-Ray SystemKPR · Traditional | 07/18/1986SE |
| K861995 | Model RS-3 Radiographic StandIYB · Traditional | 06/19/1986SE |
| K860025 | Model MS-325 Radiographic X-Ray GeneratorKPR · Traditional | 05/07/1986SE |
| K850761 | Model Pcx/Emy 525A Microprocesssor Control X-Ray CBZN · Traditional | 09/19/1985SE |
| K851358 | Model Bion 2/TYPE 90 Room IonizerFRF · Traditional | 07/01/1985SE |
| K843335 | Floor Mounted X-Ray TubestandIYB · Traditional | 11/27/1984SE |
| K840227 | UROLIX-3 Urological TableIXR · Traditional | 03/23/1984SE |
| K840225 | C-Arm Ceiling Crane FT-2JAA · Traditional | 03/22/1984SE |
| K840226 | Motor Tilted Exam. Table UV-56IXR · Traditional | 03/16/1984SE |
| K823695 | CPM Metabolic MonitorBZL · Traditional | 01/14/1983SE |
Questions and answers
When was Model Bion 1/TYPE 1084T Car Ionizer cleared by the FDA?
Model Bion 1/TYPE 1084T Car Ionizer (K851094) received a 510(k) decision of Substantially Equivalent on June 19, 1985, 92 days after the submission was received.
What is the product code of K851094?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.