Model Bion 2/TYPE 90 Room Ionizer
FDA 510(k) K851358 · Medicor USA , Ltd.
510(k) numberK851358
Submission
- Device name
- Model Bion 2/TYPE 90 Room Ionizer
- Applicant
- Medicor USA , Ltd.
Columbus, OH, US - Received
- April 4, 1985
- Decision date
- July 1, 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
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Questions and answers
When was Model Bion 2/TYPE 90 Room Ionizer cleared by the FDA?
Model Bion 2/TYPE 90 Room Ionizer (K851358) received a 510(k) decision of Substantially Equivalent on July 1, 1985, 88 days after the submission was received.
What is the product code of K851358?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.