Cleared Traditional

ECHOCARDIOGRAPHY

K945163 · Tri W-G, Inc. · General Hospital
Feb 1995
Decision
119d
Days
Class 1
Risk

About This 510(k) Submission

K945163 is an FDA 510(k) clearance for the ECHOCARDIOGRAPHY, a Table, Examination, Medical, Powered (Class I — General Controls, product code LGX), submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on February 17, 1995, 119 days after receiving the submission on October 21, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K945163 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1994
Decision Date February 17, 1995
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LGX — Table, Examination, Medical, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960