Cleared Traditional

Nebulizer

K212395 · Shenzhen Homed Medical Device Co., Ltd. · Anesthesiology
Mar 2022
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K212395 is an FDA 510(k) clearance for the Nebulizer, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Shenzhen Homed Medical Device Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 25, 2022, 235 days after receiving the submission on August 2, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K212395 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2021
Decision Date March 25, 2022
Days to Decision 235 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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