Cleared Traditional

Galapogos

K200565 · ResMed Corp · Anesthesiology
Jan 2021
Decision
319d
Days
Class 2
Risk

About This 510(k) Submission

K200565 is an FDA 510(k) clearance for the Galapogos, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on January 17, 2021, 319 days after receiving the submission on March 4, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K200565 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2020
Decision Date January 17, 2021
Days to Decision 319 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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