The following data is part of a premarket notification filed by Wide Corporation with the FDA for Wide 2mp Tft Lcd Monitor System If 1902a.
Device ID | K032960 |
510k Number | K032960 |
Device Name: | WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A |
Classification | System, Image Processing, Radiological |
Applicant | WIDE CORPORATION 1100 LAKEVIEW BLVD. Denton, TX 76208 |
Contact | Carl Alletto |
Correspondent | Ned 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 | 2003-09-23 |
Decision Date | 2003-10-08 |
Summary: | summary |