FDA 510(k)

合併心臟設備醫療設備規範文本合併心臟設備 FDA（美國食品藥品管理局） 510(k)（美國食品藥品管理局的510(k)認證程序） PMA（美國食品藥品管理局的上市前批准） NCT（臨床試驗登錄號） PMID（PubMed標識符）識別碼網址政策：醫療規範-v1

K 號：K192276 · 2019-09-20

決定日期2019-09-20

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Merge Cardio is the device name listed in this FDA 510(k) record. The listed applicant is Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K192276. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Merge Cardio?

Merge Cardio is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K192276.

When did Merge Cardio receive FDA 510(k) clearance?

Merge Cardio received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192276.

Who is the listed applicant for Merge Cardio?

The FDA 510(k) record lists Merge Healthcare Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merge Cardio?

The FDA product code for Merge Cardio is LLZ.

其他以 Merge Healthcare Incorporated 為申請人之記錄

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相關器械（代碼：LLZ）

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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