The following data is part of a premarket notification filed by Planar Systems, Inc. with the FDA for Dome Cx Digital Flat-panel Display System Model, C3 Color And C3 Gray.
Device ID | K032638 |
510k Number | K032638 |
Device Name: | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY |
Classification | System, Image Processing, Radiological |
Applicant | PLANAR SYSTEMS, INC. 400 FIFTH AVENUE Waltham, MA 02451 |
Contact | Susan Hamann |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-08-27 |
Decision Date | 2003-09-11 |
Summary: | summary |