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FDA PMA

泵,輸注,胰島素,與侵入性血糖感測器配合使用

PMA 核准號:P130007 · 2018-07-11

申請人Animas Corp.
決定日期2018-07-11
PMA 編號P130007
產品代碼OYC
器械分類3 類
醫療專科U
諮詢委員會CH

器材摘要

Pump, infusion, insulin, to be used with invasive glucose sensor is the device name listed in this FDA 510(k) record. The listed applicant is Animas Corp.. It received FDA 510(k) clearance on 2018-07-11. The device is classified under product code OYC. It was reviewed by the CH advisory panel.

常見問題

What is the Pump, infusion, insulin, to be used with invasive glucose sensor?

Pump, infusion, insulin, to be used with invasive glucose sensor is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Animas Corp..

When did Pump, infusion, insulin, to be used with invasive glucose sensor receive FDA 510(k) clearance?

The clearance date for Pump, infusion, insulin, to be used with invasive glucose sensor can be found in the official FDA records.

Who is the listed applicant for Pump, infusion, insulin, to be used with invasive glucose sensor?

The FDA 510(k) record lists Animas Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor?

The FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor is OYC.

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