Cleared Traditional

UNIVERSAL CONTROLLER, MODEL 100

K934543 · Metamed, Inc. · General Hospital

Mar 1994

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K934543 is an FDA 510(k) clearance for the UNIVERSAL CONTROLLER, MODEL 100, a Controller, Infusion, Intravascular, Electronic (Class II — Special Controls, product code LDR), submitted by Metamed, Inc. (San Diego, US). The FDA issued a Cleared decision on March 29, 1994, 194 days after receiving the submission on September 16, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K934543 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1993
Decision Date	March 29, 1994
Days to Decision	194 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement