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FDA 510(k)

手動輪椅 SIVFH2A102

K 號:K190534 · 2019-05-29

決定日期2019-05-29
產品代碼IOR
諮詢委員會PM
決定相當於

器材摘要

Manual Wheelchair SIVFH2A102 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Horizon Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-29 under 510(k) number K190534. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Manual Wheelchair SIVFH2A102?

Manual Wheelchair SIVFH2A102 is a medical device that received FDA 510(k) clearance on 2019-05-29. The listed applicant is Jiangsu Horizon Medical Science & Technology Co., Ltd.. The 510(k) number is K190534.

When did Manual Wheelchair SIVFH2A102 receive FDA 510(k) clearance?

Manual Wheelchair SIVFH2A102 received FDA 510(k) clearance on 2019-05-29, under 510(k) number K190534.

Who is the listed applicant for Manual Wheelchair SIVFH2A102?

The FDA 510(k) record lists Jiangsu Horizon Medical Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Manual Wheelchair SIVFH2A102?

The FDA product code for Manual Wheelchair SIVFH2A102 is IOR.

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相關器械(代碼:IOR)

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。

官方來源

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