Cleared Traditional

MOVES SLC

K161420 · Thornhill Research, Inc. · Anesthesiology
Jun 2017
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K161420 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 June 6, 2017, 379 days after receiving the submission on May 23, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K161420 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2016
Decision Date June 06, 2017
Days to Decision 379 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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