FDA 510(k)

GUS831壓縮式霧化器

K 號：K192633 · 2020-05-01

申請人Globalcare Medical Technology Co., Ltd.

決定日期2020-05-01

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

GUS831 Compressor Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192633. 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 GUS831 Compressor Nebulizer?

GUS831 Compressor Nebulizer is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Globalcare Medical Technology Co., Ltd.. The 510(k) number is K192633.

When did GUS831 Compressor Nebulizer receive FDA 510(k) clearance?

GUS831 Compressor Nebulizer received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192633.

Who is the listed applicant for GUS831 Compressor Nebulizer?

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

What is the FDA product code for GUS831 Compressor Nebulizer?

The FDA product code for GUS831 Compressor Nebulizer is CAF.

其他以 Globalcare Medical Technology Co., Ltd. 為申請人之記錄

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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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