Cleared Traditional

MOVES SLC

K140049 · Thornhill Research, Inc. · Anesthesiology
May 2014
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K140049 is an FDA 510(k) clearance for the MOVES SLC, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Thornhill Research, Inc. (Toronto, CA). The FDA issued a Cleared decision on May 29, 2014, 140 days after receiving the submission on January 9, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K140049 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2014
Decision Date May 29, 2014
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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