Video Plus System, Series 95000

FDA 510(k) K992666 · Camtronics, Ltd.

Substantially Equivalent

510(k) numberK992666

Submission

Device name
Video Plus System, Series 95000
Applicant
Camtronics, Ltd.
Hartland, WI, US
Received
August 9, 1999
Decision date
October 13, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Video Plus System, Series 95000 cleared by the FDA?

Video Plus System, Series 95000 (K992666) received a 510(k) decision of Substantially Equivalent on October 13, 1999, 65 days after the submission was received.

What is the product code of K992666?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.