Cleared Traditional

K182906 - Portable Mesh Nebulizer
(FDA 510(k) Clearance)

K182906 · Feellife Health, Inc. · Anesthesiology

Sep 2020

Decision

711d

Days

Class 2

Risk

K182906 is an FDA 510(k) clearance for the Portable Mesh Nebulizer, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Feellife Health, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 27, 2020, 711 days after receiving the submission on October 17, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K182906 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2018
Decision Date	September 27, 2020
Days to Decision	711 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement