View NT

FDA 510(k) K000474 · Electromed Intl., Ltd.

Substantially Equivalent

510(k) numberK000474

Submission

Device name
View NT
Applicant
Electromed Intl., Ltd.
St-Eustache, Quebec, CA
Received
February 14, 2000
Decision date
April 19, 2000
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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 View NT cleared by the FDA?

View NT (K000474) received a 510(k) decision of Substantially Equivalent on April 19, 2000, 65 days after the submission was received.

What is the product code of K000474?

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