FDA 510(k)

模型 621/624 生物磁力計

K 號：K151135 · 2016-03-15

決定日期2016-03-15

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

MODEL 621/624 BIOMAGNETOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Tristan Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-15 under 510(k) number K151135. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MODEL 621/624 BIOMAGNETOMETER?

MODEL 621/624 BIOMAGNETOMETER is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Tristan Technologies, Inc.. The 510(k) number is K151135.

When did MODEL 621/624 BIOMAGNETOMETER receive FDA 510(k) clearance?

MODEL 621/624 BIOMAGNETOMETER received FDA 510(k) clearance on 2016-03-15, under 510(k) number K151135.

Who is the listed applicant for MODEL 621/624 BIOMAGNETOMETER?

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

What is the FDA product code for MODEL 621/624 BIOMAGNETOMETER?

The FDA product code for MODEL 621/624 BIOMAGNETOMETER is DPS.

其他以 Tristan Technologies, 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。

K152184MagView 生物磁力計系統

相關器械（代碼：DPS）

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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