The following data is part of a premarket notification filed by Endomedix with the FDA for Endoscopic Video System And Endoscopic Video Camera.
| Device ID | K934623 |
| 510k Number | K934623 |
| Device Name: | ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Contact | Randy A Wilson |
| Correspondent | Randy A Wilson ENDOMEDIX 2162 MICHELSON DR. Irvine, CA 92715 -1304 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-27 |
| Decision Date | 1993-12-02 |