FDA 510(k)

PORTAGE 系統

K 號：K161878 · 2016-09-26

決定日期2016-09-26

產品代碼HRX

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決定相當於

器材摘要

PORTAGE System is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K161878. 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 PORTAGE System?

PORTAGE System is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K161878.

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

PORTAGE System received FDA 510(k) clearance on 2016-09-26, under 510(k) number K161878.

Who is the listed applicant for PORTAGE System?

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

What is the FDA product code for PORTAGE System?

The FDA product code for PORTAGE System is HRX.

其他以 Baylis Medical Company, Inc. 為申請人之記錄

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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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