FDA 510(k)

KEOPS 平衡分析儀 3D

K 號：K213975 · 2022-05-06

申請人S.M.A.I.O

決定日期2022-05-06

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

KEOPS Balance Analyzer 3D is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K213975. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KEOPS Balance Analyzer 3D?

KEOPS Balance Analyzer 3D is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is S.M.A.I.O. The 510(k) number is K213975.

When did KEOPS Balance Analyzer 3D receive FDA 510(k) clearance?

KEOPS Balance Analyzer 3D received FDA 510(k) clearance on 2022-05-06, under 510(k) number K213975.

Who is the listed applicant for KEOPS Balance Analyzer 3D?

FDA 510(k) 記錄將 S.M.A.I.O 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for KEOPS Balance Analyzer 3D?

The FDA product code for KEOPS Balance Analyzer 3D is LLZ.

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相關器械（代碼：LLZ）

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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