Cleared Traditional Expedited

MOVES

K093261 · Thornhill Research, Inc. · Anesthesiology
Mar 2010
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K093261 is an FDA 510(k) clearance for the MOVES, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Thornhill Research, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on March 26, 2010, 158 days after receiving the submission on October 19, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K093261 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2009
Decision Date March 26, 2010
Days to Decision 158 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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