FDA 510(k)

converge

K 號：K153573 · 2016-08-11

決定日期2016-08-11

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Converge is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Enterprises, Inc.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K153573. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Converge?

Converge is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Biomedical Enterprises, Inc.. The 510(k) number is K153573.

When did Converge receive FDA 510(k) clearance?

Converge received FDA 510(k) clearance on 2016-08-11, under 510(k) number K153573.

Who is the listed applicant for Converge?

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

What is the FDA product code for Converge?

The FDA product code for Converge is HRS.

相關器械（代碼：HRS）

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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