FDA 510(k)

SCIZER (SC1-M410)

K 號：K230100 · 2023-11-03

決定日期2023-11-03

產品代碼OHV

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

SCIZER (SC1-M410) is the device name listed in this FDA 510(k) record. The listed applicant is Classys, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K230100. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SCIZER (SC1-M410)?

SCIZER (SC1-M410) is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Classys, Inc.. The 510(k) number is K230100.

When did SCIZER (SC1-M410) receive FDA 510(k) clearance?

SCIZER (SC1-M410) received FDA 510(k) clearance on 2023-11-03, under 510(k) number K230100.

Who is the listed applicant for SCIZER (SC1-M410)?

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

What is the FDA product code for SCIZER (SC1-M410)?

The FDA product code for SCIZER (SC1-M410) is OHV.

其他以 Classys, Inc. 為申請人之記錄

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相關器械（代碼：OHV）

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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