FDA 510(k)

嗨-道 PRO 觸控無線 6-12 (HD-19A)

K 號：K233461 · 2024-01-19

決定日期2024-01-19

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K233461. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K233461.

When did Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) receive FDA 510(k) clearance?

Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) received FDA 510(k) clearance on 2024-01-19, under 510(k) number K233461.

Who is the listed applicant for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)?

The FDA product code for Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) is NUH.

其他以 Hi-Dow International, Inc. 為申請人之記錄

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