The following data is part of a premarket notification filed by Leedal, Inc. with the FDA for Dotrich Electronic Air Cleaner #c500am.
| Device ID | K812656 |
| 510k Number | K812656 |
| Device Name: | DOTRICH ELECTRONIC AIR CLEANER #C500AM |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | LEEDAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-18 |
| Decision Date | 1981-10-08 |