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FDA PMA

自動胰島素劑量,閾值暫停

PMA 核准號:P180008 · 2019-12-19

決定日期2019-12-19
PMA 編號P180008
產品代碼OZO
器械分類3 類
醫療專科U
諮詢委員會CH

器材摘要

Automated insulin dosing , threshold suspend is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2019-12-19. The device is classified under product code OZO. It was reviewed by the CH advisory panel.

常見問題

What is the Automated insulin dosing , threshold suspend?

Automated insulin dosing , threshold suspend is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Tandem Diabetes Care, Inc..

When did Automated insulin dosing , threshold suspend receive FDA 510(k) clearance?

The clearance date for Automated insulin dosing , threshold suspend can be found in the official FDA records.

誰是自動胰島素劑量、閾值暫停的登記申請人?

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

FDA自動調節胰島素劑量、閾值暫停產品代碼是什麼?

FDA自動調節胰島素劑量、閾值暫停產品代碼為OZO。

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官方來源

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