510(k) K875233

VARIVIEWER (X-RAY FILM VIEWER) by Diversified Diagnostic Products, Inc. — Product Code IXC

K875233 is an FDA 510(k) premarket notification submitted by Diversified Diagnostic Products, Inc. for the device "VARIVIEWER (X-RAY FILM VIEWER)". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code IXC (Illuminator, Radiographic-Film), a Class I device regulated under 21 CFR 892.1890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
December 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Radiographic-Film
Device Class
Class I
Regulation Number
892.1890
Review Panel
RA
Submission Type