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FDA 510(k)

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

K-Number: K161586 · 2017-09-06

ApplicantShenzhen Homed Medical Device Co., Ltd.
Decision Date2017-09-06
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is a medical device manufactured by Shenzhen Homed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2017-09-06 under approval number K161586. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is a medical device that received FDA 510(k) clearance on 2017-09-06. It is manufactured by Shenzhen Homed Medical Device Co., Ltd.. The 510(k) number is K161586.

When was The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) approved by the FDA?

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) received FDA 510(k) clearance on 2017-09-06, under approval number K161586.

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

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is manufactured by Shenzhen Homed Medical Device Co., Ltd..

What is the FDA product code for The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)?

The FDA product code for The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is CAF.

Related Clinical Trials

NCT02875964 Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings. COMPLETED

Other Devices by Shenzhen Homed Medical Device Co., Ltd.

K170886HOMED Mesh Nebulizer K212395Nebulizer K252616Portable oxygen concentrator (JLO-190P)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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