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 |