FDA 510(k)

HS186B 車輪腳踏車

K 號：K222711 · 2023-01-09

申請人Suzhou Master Machinery Manufacturing Co.,Ltd

決定日期2023-01-09

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

HS186B Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Master Machinery Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2023-01-09 under 510(k) number K222711. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HS186B Scooter?

HS186B Scooter is a medical device that received FDA 510(k) clearance on 2023-01-09. The listed applicant is Suzhou Master Machinery Manufacturing Co.,Ltd. The 510(k) number is K222711.

When did HS186B Scooter receive FDA 510(k) clearance?

HS186B Scooter received FDA 510(k) clearance on 2023-01-09, under 510(k) number K222711.

Who is the listed applicant for HS186B Scooter?

The FDA 510(k) record lists Suzhou Master Machinery Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HS186B Scooter?

The FDA product code for HS186B Scooter is INI.

其他以 Suzhou Master Machinery Manufacturing Co.,Ltd 為申請人之記錄

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相關器械（代碼：INI）

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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