The following data is part of a premarket notification filed by Vista Medical Technologies, Inc. with the FDA for Vista Visualization System, Model 9000, Vista Visualization System With Voice Activation And Pip, Model 9100.
| Device ID | K021290 |
| 510k Number | K021290 |
| Device Name: | VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100 |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-23 |
| Decision Date | 2002-06-28 |
| Summary: | summary |