FDA 510(k)

TAP血液收集設備

K 號：K161521 · 2017-02-16

決定日期2017-02-16

產品代碼PRJ

諮詢委員會CH

決定相當於

器材摘要

TAP Blood Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Seventh Sense Biosystems, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K161521. The device is classified under product code PRJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TAP Blood Collection Device?

TAP Blood Collection Device is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Seventh Sense Biosystems, Inc.. The 510(k) number is K161521.

When did TAP Blood Collection Device receive FDA 510(k) clearance?

TAP Blood Collection Device received FDA 510(k) clearance on 2017-02-16, under 510(k) number K161521.

Who is the listed applicant for TAP Blood Collection Device?

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

What is the FDA product code for TAP Blood Collection Device?

The FDA product code for TAP Blood Collection Device is PRJ.

其他以 Seventh Sense Biosystems, Inc. 為申請人之記錄

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K190225TAP血液收集設備

相關器械（代碼：PRJ）

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。

K190225TAP血液收集設備Seventh Sense Biosystems, Inc.

官方來源

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