Cleared Traditional

TRACH-ASSIST

K083702 · Mergenet Medical · Anesthesiology

Mar 2009

Decision

80d

Days

Class 1

Risk

About This 510(k) Submission

K083702 is an FDA 510(k) clearance for the TRACH-ASSIST, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Mergenet Medical (Bonita Springs, US). The FDA issued a Cleared decision on March 5, 2009, 80 days after receiving the submission on December 15, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number	K083702 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2008
Decision Date	March 05, 2009
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF