FDA 510(k)

E ブラトアー

K番号: K251899 · 2025-10-01

決定日2025-10-01

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

E Blator is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K251899. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the E Blator?

E Blator is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K251899.

When did E Blator receive FDA 510(k) clearance?

E Blator received FDA 510(k) clearance on 2025-10-01, under 510(k) number K251899.

Who is the listed applicant for E Blator?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E Blator?

The FDA product code for E Blator is GEI.

申請者としてNew Deantronics Taiwan , Ltd.を記載するその他の記録

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