The following data is part of a premarket notification filed by Sony Electronics, Inc. with the FDA for Sony Up-df750 Digital Film Imager.
Device ID | K083522 |
510k Number | K083522 |
Device Name: | SONY UP-DF750 DIGITAL FILM IMAGER |
Classification | Camera, Multi Format, Radiological |
Applicant | SONY ELECTRONICS, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
Contact | Cynthia Sinclair |
Correspondent | Cynthia Sinclair SONY ELECTRONICS, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-26 |
Decision Date | 2009-01-09 |
Summary: | summary |