FDA 510(k)

PatCom單次使用導入器

K 號：K192691 · 2020-02-21

決定日期2020-02-21

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

PatCom Single-Use Introducer is the device name listed in this FDA 510(k) record. The listed applicant is H&A Mui Enterprises, Inc.. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K192691. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PatCom Single-Use Introducer?

PatCom Single-Use Introducer is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is H&A Mui Enterprises, Inc.. The 510(k) number is K192691.

When did PatCom Single-Use Introducer receive FDA 510(k) clearance?

PatCom Single-Use Introducer received FDA 510(k) clearance on 2020-02-21, under 510(k) number K192691.

Who is the listed applicant for PatCom Single-Use Introducer?

The FDA 510(k) record lists H&A Mui Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PatCom Single-Use Introducer?

The FDA product code for PatCom Single-Use Introducer is FED.

其他以 H&A Mui Enterprises, Inc. 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。

K222587PatCom 遠端芯片內視鏡

相關器械（代碼：FED）

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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