FDA 510(k)

Fit Pro 乳罩抽乳器

K 號：K212955 · 2022-03-15

決定日期2022-03-15

產品代碼HGX

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Fit Pro Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia II Medical Group, Inc.. It received FDA 510(k) clearance on 2022-03-15 under 510(k) number K212955. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fit Pro Breast Pump?

Fit Pro Breast Pump is a medical device that received FDA 510(k) clearance on 2022-03-15. The listed applicant is Hygeia II Medical Group, Inc.. The 510(k) number is K212955.

When did Fit Pro Breast Pump receive FDA 510(k) clearance?

Fit Pro Breast Pump received FDA 510(k) clearance on 2022-03-15, under 510(k) number K212955.

Who is the listed applicant for Fit Pro Breast Pump?

The FDA 510(k) record lists Hygeia II Medical Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fit Pro Breast Pump?

The FDA product code for Fit Pro Breast Pump is HGX.

其他以 Hygeia II Medical Group, Inc. 為申請人之記錄

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K233136Hygeia Express 電動乳泵 K200406進化母乳泵 K190465進化母乳泵

相關器械（代碼：HGX）

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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