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FDA 510(k)

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)

K 號：K254210 · 2026-09-25

申請人Hyundai Bioland Co., Ltd.
決定日期2026-09-25
產品代碼NPM
諮詢委員會DE
決定Substantially Equivalent

器材摘要

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) is the device name listed in this FDA 510(k) record. The listed applicant is Hyundai Bioland Co., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K254210. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)?

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Hyundai Bioland Co., Ltd.. The 510(k) number is K254210.

When did REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) receive FDA 510(k) clearance?

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K254210.

Who is the listed applicant for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)?

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

What is the FDA product code for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)?

The FDA product code for REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) is NPM.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：NPM）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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