GBT Machine Airflow Prophylaxis Master
K-Number: K253254 · 2026-01-28
ApplicantE.M.S Electro Medical Systems S.A
Decision Date2026-01-28
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GBT Machine Airflow Prophylaxis Master is a medical device manufactured by E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2026-01-28 under approval number K253254. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by E.M.S Electro Medical Systems S.A. The 510(k) number is K253254.
When was GBT Machine Airflow Prophylaxis Master approved by the FDA?
GBT Machine Airflow Prophylaxis Master received FDA 510(k) clearance on 2026-01-28, under approval number K253254.
What company makes GBT Machine Airflow Prophylaxis Master?
GBT Machine Airflow Prophylaxis Master is manufactured by E.M.S Electro Medical Systems S.A.
What is the FDA product code for GBT Machine Airflow Prophylaxis Master?
The FDA product code for GBT Machine Airflow Prophylaxis Master is ELC.
Other Devices by E.M.S Electro Medical Systems S.A
Related Devices (Code: ELC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.