The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Video Urodynamics Sys 1906b-y & 1906c-y.
| Device ID | K843198 |
| 510k Number | K843198 |
| Device Name: | VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | LIFE-TECH INTL., 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 | 1984-08-14 |
| Decision Date | 1984-10-04 |