FDA 510(k)

GBT Machine Airflow Prophylaxis Master

K-번호: K253254 · 2026-01-28

결정일2026-01-28

제품 코드ELC

자문 위원회DE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

E.M.S Electro Medical Systems S.A를 신청인으로 등재한 기타 기록

K243279DOLORCLAST Focused Shock Waves K230893Swiss LthoClast Trilogy K220538DolorClast Radial K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One K191079Piezon Built-in Kit, Piezon Built-in Kit LED K191124Swiss LithoClast Trilogy

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