Cleared Traditional

RESCAN

K140054 · Resmed, Ltd. · Anesthesiology
May 2014
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K140054 is an FDA 510(k) clearance for the RESCAN, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on May 16, 2014, 127 days after receiving the submission on January 9, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K140054 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2014
Decision Date May 16, 2014
Days to Decision 127 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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