Hepacron Pureair-Zone System
FDA 510(k) K862432 · Hepacron, Inc.
510(k) numberK862432
Submission
- Device name
- Hepacron Pureair-Zone System
- Applicant
- Hepacron, Inc.
Louisville, KY, US - Received
- June 26, 1986
- Decision date
- October 16, 1986
- 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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| 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 |
Questions and answers
When was Hepacron Pureair-Zone System cleared by the FDA?
Hepacron Pureair-Zone System (K862432) received a 510(k) decision of Substantially Equivalent on October 16, 1986, 112 days after the submission was received.
What is the product code of K862432?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.