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FDA 510(k)

GBT機器空氣流預防主機

K 號:K253254 · 2026-01-28

決定日期2026-01-28
產品代碼ELC
諮詢委員會DE
決定相當於

器材摘要

GBT Machine Airflow Prophylaxis Master is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K253254. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GBT Machine Airflow Prophylaxis Master?

GBT Machine Airflow Prophylaxis Master is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K253254.

When did GBT Machine Airflow Prophylaxis Master receive FDA 510(k) clearance?

GBT Machine Airflow Prophylaxis Master received FDA 510(k) clearance on 2026-01-28, under 510(k) number K253254.

Who is the listed applicant for GBT Machine Airflow Prophylaxis Master?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GBT Machine Airflow Prophylaxis Master?

The FDA product code for GBT Machine Airflow Prophylaxis Master is ELC.

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其他以 E.M.S Electro Medical Systems S.A 為申請人之記錄

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相關器械(代碼:ELC)

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