Cleared Traditional

AIRTRAQ SP AIRTRAQ AVANT

K121378 · Prodol Meditec , Ltd. · Anesthesiology

Jun 2012

Decision

44d

Days

Class 1

Risk

About This 510(k) Submission

K121378 is an FDA 510(k) clearance for the AIRTRAQ SP AIRTRAQ AVANT, a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Prodol Meditec , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on June 21, 2012, 44 days after receiving the submission on May 8, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number	K121378 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2012
Decision Date	June 21, 2012
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF