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, Models C2 And C5i.
| Device ID | K032202 |
| 510k Number | K032202 |
| Device Name: | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I |
| Classification | System, Image Processing, Radiological |
| Applicant | PLANAR SYSTEMS, INC. 400 FIFTH AVENUE Waltham, MA 02451 |
| Contact | Susan Hamann |
| Correspondent | Ned E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-18 |
| Decision Date | 2003-08-01 |
| Summary: | summary |