Cleared Traditional

MADM

K140264 · Thornhill Research, Inc. · Anesthesiology
Jan 2015
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K140264 is an FDA 510(k) clearance for the MADM, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Thornhill Research, Inc. (Toronto, CA). The FDA issued a Cleared decision on January 5, 2015, 336 days after receiving the submission on February 3, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K140264 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2014
Decision Date January 05, 2015
Days to Decision 336 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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