The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Viotec 1400 Series Ultraviolet Germicidal Fixture.
| Device ID | K943521 |
| 510k Number | K943521 |
| Device Name: | VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE |
| Classification | Purifier, Air, Ultraviolet, Medical |
| Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | FRA |
| CFR Regulation Number | 880.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-20 |
| Decision Date | 1995-02-14 |