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FDA PMA

感測器、血糖、侵入性、非輔助性、工廠校準、使用者啟動

PMA 核准號:P160030 · 2026-09-01

決定日期2026-09-01
PMA 編號P160030
產品代碼PZE
器械分類3 類
醫療專科U
諮詢委員會CH

器材摘要

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2026-09-01. The device is classified under product code PZE. It was reviewed by the CH advisory panel.

常見問題

What is the Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated?

Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Abbott Diabetes Care, Inc..

When did Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated receive FDA 510(k) clearance?

The clearance date for Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated can be found in the official FDA records.

誰是Sensor,葡萄糖,侵入性,非輔助性,工廠校準,使用者啟動的登記申請人?

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

FDA產品代碼為Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated是什麼?

FDA產品代碼為Sensor、葡萄糖、侵入性、非輔助、工廠校準、使用者啟動的是PZE。

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官方來源

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