Cleared Abbreviated

K990759 - VIEW COM
(FDA 510(k) Clearance)

K990759 · Electromed Intl., Ltd. · Radiology
Apr 1999
Decision
38d
Days
Class 2
Risk

K990759 is an FDA 510(k) clearance for the VIEW COM, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Electromed Intl., Ltd. (St-Eustache, Quebec, CA). The FDA issued a Cleared decision on April 15, 1999, 38 days after receiving the submission on March 8, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K990759 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1999
Decision Date April 15, 1999
Days to Decision 38 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050