FDA 510(k)

ABSOLU

K 號：K183414 · 2019-03-20

決定日期2019-03-20

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

ABSOLU is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2019-03-20 under 510(k) number K183414. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ABSOLU?

ABSOLU is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is Quantel Medical. The 510(k) number is K183414.

When did ABSOLU receive FDA 510(k) clearance?

ABSOLU received FDA 510(k) clearance on 2019-03-20, under 510(k) number K183414.

Who is the listed applicant for ABSOLU?

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

What is the FDA product code for ABSOLU?

The FDA product code for ABSOLU is IYO.

其他以 Quantel Medical 為申請人之記錄

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。

K251507INTEGRE LIO醫療設備規範文本翻譯： INTEGRE LIO K232302口袋III K220430醫療設備名稱：Capsulo 醫療設備規範文本：FDA、510(k)、PMA、NCT、PMID、識別碼及網址政策：medical-regulatory-v1 翻譯結果：Capsulo K213254Axialis眼科超音波系統 K201502維特拉810 K191962維特拉2

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相關器械（代碼：IYO）

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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