The following data is part of a premarket notification filed by Sony Medical Electronics Co. with the FDA for Sony Dxc-ls1 Color Video Camera.
| Device ID | K980279 |
| 510k Number | K980279 |
| Device Name: | SONY DXC-LS1 COLOR VIDEO CAMERA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SONY MEDICAL ELECTRONICS CO. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair SONY MEDICAL ELECTRONICS CO. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-26 |
| Decision Date | 1998-04-24 |
| Summary: | summary |