The following data is part of a premarket notification filed by Diversified Diagnostic Products, Inc. with the FDA for Variviewer (x-ray Film Viewer).
Device ID | K875233 |
510k Number | K875233 |
Device Name: | VARIVIEWER (X-RAY FILM VIEWER) |
Classification | Illuminator, Radiographic-film |
Applicant | DIVERSIFIED DIAGNOSTIC PRODUCTS, INC. 11603 WINDFERN Houston, TX 77064 |
Contact | Gerald Timpe |
Correspondent | Gerald Timpe DIVERSIFIED DIAGNOSTIC PRODUCTS, INC. 11603 WINDFERN Houston, TX 77064 |
Product Code | IXC |
CFR Regulation Number | 892.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-01-19 |