The following data is part of a premarket notification filed by Sony Medical Electronics Co. with the FDA for Sony Dvr-10 Digital Videocassette Recorder.
| Device ID | K913886 |
| 510k Number | K913886 |
| Device Name: | SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SONY MEDICAL ELECTRONICS CO. 3 PARAGON DR. Montvale, NJ 07645 |
| Contact | Lynne M Bennett |
| Correspondent | Lynne M Bennett SONY MEDICAL ELECTRONICS CO. 3 PARAGON DR. Montvale, NJ 07645 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1992-01-24 |