FDA 510(k)

洞察 BD

K 號：K172832 · 2018-02-06

決定日期2018-02-06

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Insight BD is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2018-02-06 under 510(k) number K172832. 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 Insight BD?

Insight BD is a medical device that received FDA 510(k) clearance on 2018-02-06. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K172832.

When did Insight BD receive FDA 510(k) clearance?

Insight BD received FDA 510(k) clearance on 2018-02-06, under 510(k) number K172832.

Who is the listed applicant for Insight BD?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insight BD?

The FDA product code for Insight BD is LLZ.

其他以 Siemens Medi Cal Solutions, Inc. 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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