The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Olympus Kc-10 Mobile Disinfec-stat.
| Device ID | K841331 |
| 510k Number | K841331 |
| Device Name: | OLYMPUS KC-10 MOBILE DISINFEC-STAT |
| Classification | Accessories, Germicide, Cleaning, For Endoscopes |
| Applicant | KEYMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | NZA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-07-19 |