The following data is part of a premarket notification filed by Sony Medical Systems with the FDA for Sony Laser Videodisc Recording System.
| Device ID | K921275 |
| 510k Number | K921275 |
| Device Name: | SONY LASER VIDEODISC RECORDING SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | SONY MEDICAL SYSTEMS CYNTHIA A. SINCLAIR 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair SONY MEDICAL SYSTEMS CYNTHIA A. SINCLAIR 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-20 |
| Decision Date | 1992-06-10 |