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FDA 510(k)

Ossler檢查範圍

K 號：K171188 · 2017-06-23

申請人Lr Med, Inc.
決定日期2017-06-23
產品代碼DRG
諮詢委員會履歷
決定相當於

器材摘要

Ossler Exam Scope is the device name listed in this FDA 510(k) record. The listed applicant is Lr Med, Inc.. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K171188. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ossler Exam Scope?

Ossler Exam Scope is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Lr Med, Inc.. The 510(k) number is K171188.

When did Ossler Exam Scope receive FDA 510(k) clearance?

Ossler Exam Scope received FDA 510(k) clearance on 2017-06-23, under 510(k) number K171188.

Who is the listed applicant for Ossler Exam Scope?

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

What is the FDA product code for Ossler Exam Scope?

The FDA product code for Ossler Exam Scope is DRG.

相關臨床試驗

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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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