The following data is part of a premarket notification filed by Planar Systems, Inc. with the FDA for Planar Dome Ex Series Digital Flat-panel Display System, Model E4c Color.
Device ID | K060136 |
510k Number | K060136 |
Device Name: | PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR |
Classification | System, Image Processing, Radiological |
Applicant | PLANAR SYSTEMS, INC. 1195 NW COMPTON DRIVE Beaverton, OR 97006 |
Contact | Craig Harshman |
Correspondent | Melissa J Deguia UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-01-19 |
Decision Date | 2006-01-31 |
Summary: | summary |