The following data is part of a premarket notification filed by Mitsubishi Electric Corporation Kyoto Works with the FDA for Digital Printer P6000d Series, Model P6000du.
Device ID | K061302 |
510k Number | K061302 |
Device Name: | DIGITAL PRINTER P6000D SERIES, MODEL P6000DU |
Classification | Camera, Multi Format, Radiological |
Applicant | MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS 319 AKENO, OBATA-CHO Ise-shi, JP Mie-ken |
Contact | Shinichi Yamanaka |
Correspondent | Shinichi Yamanaka MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS 319 AKENO, OBATA-CHO Ise-shi, JP Mie-ken |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-10 |
Decision Date | 2006-06-23 |
Summary: | summary |