The following data is part of a premarket notification filed by Umi, Inc. with the FDA for Crm-114 Color Video Camera.
| Device ID | K830924 |
| 510k Number | K830924 |
| Device Name: | CRM-114 COLOR VIDEO CAMERA |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | UMI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-22 |
| Decision Date | 1983-04-18 |