FDA 510(k)

BEE HA

K 號：K250560 · 2025-11-21

決定日期2025-11-21

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

BEE HA is the device name listed in this FDA 510(k) record. The listed applicant is NGMedical GmbH. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K250560. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BEE HA?

BEE HA is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is NGMedical GmbH. The 510(k) number is K250560.

When did BEE HA receive FDA 510(k) clearance?

BEE HA received FDA 510(k) clearance on 2025-11-21, under 510(k) number K250560.

Who is the listed applicant for BEE HA?

The FDA 510(k) record lists NGMedical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEE HA?

The FDA product code for BEE HA is ODP.

其他以 NGMedical GmbH 為申請人之記錄

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相關器械（代碼：ODP）

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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