The following data is part of a premarket notification filed by Medair, Inc. with the FDA for Ics 9400 Ultraviolet Air Purifier.
| Device ID | K934914 |
| 510k Number | K934914 |
| Device Name: | ICS 9400 ULTRAVIOLET AIR PURIFIER |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | MEDAIR, INC. 8920 BUSINESS PARK DR. SUITE 120-A Austin, TX 78759 |
| Contact | William S Ebersole |
| Correspondent | William S Ebersole MEDAIR, INC. 8920 BUSINESS PARK DR. SUITE 120-A Austin, TX 78759 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-13 |
| Decision Date | 1994-04-13 |