FDA 510(k)

HnX-P1, HnX-PB

K 號：K251223 · 2025-08-04

決定日期2025-08-04

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

HnX-P1, HnX-PB is the device name listed in this FDA 510(k) record. The listed applicant is H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2025-08-04 under 510(k) number K251223. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HnX-P1, HnX-PB?

HnX-P1, HnX-PB is a medical device that received FDA 510(k) clearance on 2025-08-04. The listed applicant is H&abyz Co., Ltd.. The 510(k) number is K251223.

When did HnX-P1, HnX-PB receive FDA 510(k) clearance?

HnX-P1, HnX-PB received FDA 510(k) clearance on 2025-08-04, under 510(k) number K251223.

Who is the listed applicant for HnX-P1, HnX-PB?

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

What is the FDA product code for HnX-P1, HnX-PB?

The FDA product code for HnX-P1, HnX-PB is IZL.

其他以 H&abyz Co., Ltd. 為申請人之記錄

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：IZL）

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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