Cleared Traditional

VENTLINK SYSTEM

K052751 · Mediserve Information Systems, Inc. · Anesthesiology

Dec 2005

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K052751 is an FDA 510(k) clearance for the VENTLINK SYSTEM, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Mediserve Information Systems, Inc. (Tempe, US). The FDA issued a Cleared decision on December 23, 2005, 84 days after receiving the submission on September 30, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K052751 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2005
Decision Date	December 23, 2005
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF