The following data is part of a premarket notification filed by Med-western Electronics, Inc. with the FDA for View-lite, Model-dl.
Device ID | K802216 |
510k Number | K802216 |
Device Name: | VIEW-LITE, MODEL-DL |
Classification | Illuminator, Radiographic-film |
Applicant | MED-WESTERN ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IXC |
CFR Regulation Number | 892.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-12 |
Decision Date | 1980-10-23 |