FDA 510(k)

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K 號：K191345 · 2019-07-17

決定日期2019-07-17

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

Pegasus System is the device name listed in this FDA 510(k) record. The listed applicant is A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K191345. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pegasus System?

Pegasus System is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K191345.

When did Pegasus System receive FDA 510(k) clearance?

Pegasus System received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191345.

Who is the listed applicant for Pegasus System?

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

What is the FDA product code for Pegasus System?

The FDA product code for Pegasus System is HRX.

其他以 A.M. Surgical, Inc. 為申請人之記錄

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。

K191771SECURE 螺釘 K180087A.M. 外科髓內固定設備

相關器械（代碼：HRX）

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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