The following data is part of a premarket notification filed by Sony Medical Electronics Co. with the FDA for Sony Wbs-700h Videocassette Recorder System.
| Device ID | K902535 |
| 510k Number | K902535 |
| Device Name: | SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SONY MEDICAL ELECTRONICS CO. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | A Sinclair |
| Correspondent | A Sinclair SONY MEDICAL ELECTRONICS CO. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-08 |
| Decision Date | 1990-06-29 |