The following data is part of a premarket notification filed by Sony Electronics, Inc. with the FDA for Sony Hybird Graphic Up-971ad, Sony Hybird Graphic Printer Up-991ad.
| Device ID | K141346 |
| 510k Number | K141346 |
| Device Name: | SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD |
| Classification | Camera, Multi Format, Radiological |
| Applicant | SONY ELECTRONICS, INC. 62 FOREST ST. STE 300 Marlborough, MA 01752 |
| Contact | Joanne Bronikowski |
| Correspondent | Joanne Bronikowski SONY ELECTRONICS, INC. 62 FOREST ST. STE 300 Marlborough, MA 01752 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-22 |
| Decision Date | 2014-06-26 |
| Summary: | summary |