FDA 510(k)

石檢查器

K 號：K191530 · 2019-09-26

決定日期2019-09-26

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

StoneChecker is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Biometrics, LLC. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K191530. 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 StoneChecker?

StoneChecker is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Imaging Biometrics, LLC. The 510(k) number is K191530.

When did StoneChecker receive FDA 510(k) clearance?

StoneChecker received FDA 510(k) clearance on 2019-09-26, under 510(k) number K191530.

Who is the listed applicant for StoneChecker?

The FDA 510(k) record lists Imaging Biometrics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StoneChecker?

The FDA product code for StoneChecker is LLZ.

其他以 Imaging Biometrics, LLC 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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官方來源

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