The following data is part of a premarket notification filed by Konica Medical And Graphic Corporation with the FDA for Konica Laser Imager, Model Drypro Model 771.
Device ID | K032681 |
510k Number | K032681 |
Device Name: | KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 |
Classification | Camera, Multi Format, Radiological |
Applicant | KONICA MEDICAL AND GRAPHIC CORPORATION 319 AKENO, OBATA-CHO WATARAI-GUN Mie-ken, JP |
Contact | Shinichi Yamanaka |
Correspondent | Shinichi Yamanaka KONICA MEDICAL AND GRAPHIC CORPORATION 319 AKENO, OBATA-CHO WATARAI-GUN Mie-ken, JP |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-29 |
Decision Date | 2003-09-24 |