Cleared Traditional

NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET

K063477 · Novamed, LLC · Anesthesiology

Feb 2007

Decision

85d

Days

Class 1

Risk

About This 510(k) Submission

K063477 is an FDA 510(k) clearance for the NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET, a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Novamed, LLC (Bonita Springs, US). The FDA issued a Cleared decision on February 9, 2007, 85 days after receiving the submission on November 16, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number	K063477 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2006
Decision Date	February 09, 2007
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF