Cleared Traditional

DOUBLE TRACH SEIVEL CONNECTOR

K940544 · Fvtnks · Anesthesiology

Apr 1994

Decision

71d

Days

Class 1

Risk

About This 510(k) Submission

K940544 is an FDA 510(k) clearance for the DOUBLE TRACH SEIVEL CONNECTOR, a Connector, Airway (extension) (Class I — General Controls, product code BZA), submitted by Fvtnks (Indianapolis, US). The FDA issued a Cleared decision on April 19, 1994, 71 days after receiving the submission on February 7, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5810.

Submission Details

510(k) Number	K940544 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 1994
Decision Date	April 19, 1994
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement