FDA 510(k)

無菌Eol自動針筒；無菌Eol針筒プラス

K番号: K243533 · 2025-01-13

決定日2025-01-13

製品コードFMK

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

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is the device name listed in this FDA 510(k) record. The listed applicant is Hlb Co., Ltd. Healthcare. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K243533. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Hlb Co., Ltd. Healthcare. The 510(k) number is K243533.

When did Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus receive FDA 510(k) clearance?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243533.

Who is the listed applicant for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

The FDA 510(k) record lists Hlb Co., Ltd. Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

The FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is FMK.

公式ソース

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無菌Eol自動針筒；無菌Eol針筒プラス

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FMK）

公式ソース