The following data is part of a premarket notification filed by Vista Medical Technologies, Inc. with the FDA for Modification To Vista Stereoscope System.
| Device ID | K020301 |
| 510k Number | K020301 |
| Device Name: | MODIFICATION TO VISTA STEREOSCOPE SYSTEM |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | VISTA MEDICAL TECHNOLOGIES, INC. 134 FLANDERS RD. Westborough, MA 01581 |
| Contact | Graham Baillie |
| Correspondent | Graham Baillie VISTA MEDICAL TECHNOLOGIES, INC. 134 FLANDERS RD. Westborough, MA 01581 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-29 |
| Decision Date | 2002-02-12 |
| Summary: | summary |