The following data is part of a premarket notification filed by Del Medical Systems Corp. with the FDA for S-57 Video Imaging System.
| Device ID | K962024 |
| 510k Number | K962024 |
| Device Name: | S-57 VIDEO IMAGING SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | DEL MEDICAL SYSTEMS CORP. ONE COMMERCE PARK Valhalla, NY 10595 |
| Contact | Karl J Weydig |
| Correspondent | Karl J Weydig DEL MEDICAL SYSTEMS CORP. ONE COMMERCE PARK Valhalla, NY 10595 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-23 |
| Decision Date | 1996-07-09 |