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FDA 510(k)

ANAM 測試系統

K 號：K201376 · 2021-03-25

申請人Vista Lifesciences, Inc.
決定日期2021-03-25
產品代碼POM
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

ANAM Test System is the device name listed in this FDA 510(k) record. The listed applicant is Vista Lifesciences, Inc.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K201376. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ANAM Test System?

ANAM Test System is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Vista Lifesciences, Inc.. The 510(k) number is K201376.

When did ANAM Test System receive FDA 510(k) clearance?

ANAM Test System received FDA 510(k) clearance on 2021-03-25, under 510(k) number K201376.

Who is the listed applicant for ANAM Test System?

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

What is the FDA product code for ANAM Test System?

The FDA product code for ANAM Test System is POM.

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官方來源

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