FDA 510(k)

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

Número K: K161586 · 2017-09-06

RequerenteShenzhen Homed Medical Device Co., Ltd.

Data da decisão2017-09-06

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Shenzhen Homed Medical Device Co., Ltd.. The 510(k) number is K161586.

When did The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) receive FDA 510(k) clearance?

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 510(k) number K161586.

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

The FDA 510(k) record lists Shenzhen Homed Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Fonte oficial

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