The following data is part of a premarket notification filed by Airistar Technologies, Llc with the FDA for Airistar Air Purification System, Model 500 & 1000.
| Device ID | K072185 |
| 510k Number | K072185 |
| Device Name: | AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | AIRISTAR TECHNOLOGIES, LLC PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2008-03-27 |
| Summary: | summary |