Cleared Traditional

GUS831 Compressor Nebulizer

K192633 · Globalcare Medical Technology Co., Ltd. · Anesthesiology
May 2020
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K192633 is an FDA 510(k) clearance for the GUS831 Compressor Nebulizer, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Globalcare Medical Technology Co., Ltd. (Xiaolan Town, Zhongshan City, CN). The FDA issued a Cleared decision on May 1, 2020, 221 days after receiving the submission on September 23, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K192633 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2019
Decision Date May 01, 2020
Days to Decision 221 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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