View Com

FDA 510(k) K990759 · Electromed Intl., Ltd.

Substantially Equivalent

510(k) numberK990759

Submission

Device name
View Com
Applicant
Electromed Intl., Ltd.
St-Eustache, Quebec, CA
Received
March 8, 1999
Decision date
April 15, 1999
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 Com cleared by the FDA?

View Com (K990759) received a 510(k) decision of Substantially Equivalent on April 15, 1999, 38 days after the submission was received.

What is the product code of K990759?

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