The following data is part of a premarket notification filed by Vista Medical Technologies, Inc. with the FDA for Head Mounted Display.
| Device ID | K961800 |
| 510k Number | K961800 |
| Device Name: | HEAD MOUNTED DISPLAY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | VISTA MEDICAL TECHNOLOGIES, INC. 5451 AVENIDA ENCINAS, SUITE A Carlsbad, CA 92008 |
| Contact | Debbie Iampietro |
| Correspondent | Debbie Iampietro VISTA MEDICAL TECHNOLOGIES, INC. 5451 AVENIDA ENCINAS, SUITE A Carlsbad, CA 92008 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-09-11 |
| Summary: | summary |