Hepairx Ventilating Air Purifier
FDA 510(k) K112728 · Air Innovations, Inc.
510(k) numberK112728
Submission
- Device name
- Hepairx Ventilating Air Purifier
- Applicant
- Air Innovations, Inc.
North Syracuse, NY, US - Received
- September 20, 2011
- Decision date
- January 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Hepairx Ventilating Air Purifier cleared by the FDA?
Hepairx Ventilating Air Purifier (K112728) received a 510(k) decision of Substantially Equivalent on January 23, 2013, 491 days after the submission was received.
What is the product code of K112728?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.