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FDA 510(k)

JLN-23XX系列活塞壓縮霧化器（含型號JLN-2300AS、JLN-2301AS、JLN-2317AS及JLN-2320AS）

K 號：K161586 · 2017-09-06

申請人Shenzhen Homed Medical Device Co., Ltd.
決定日期2017-09-06
產品代碼CAF
諮詢委員會AN
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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其他以 Shenzhen Homed Medical Device Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：CAF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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