Cleared Traditional

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)

K161586 · Shenzhen Homed Medical Device Co., Ltd. · Anesthesiology

Sep 2017

Decision

455d

Days

Class 2

Risk

About This 510(k) Submission

K161586 is an FDA 510(k) clearance for the The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS), 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 September 6, 2017, 455 days after receiving the submission on June 8, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K161586 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2016
Decision Date	September 06, 2017
Days to Decision	455 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF