FDA 510(k)

十進位針劑

K 號：K211511 · 2021-07-01

決定日期2021-07-01

產品代碼MUJ

諮詢委員會RA

決定相當於

器材摘要

decimal Bolus is the device name listed in this FDA 510(k) record. The listed applicant is .Decimal, LLC. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K211511. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the decimal Bolus?

decimal Bolus is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is .Decimal, LLC. The 510(k) number is K211511.

When did decimal Bolus receive FDA 510(k) clearance?

decimal Bolus received FDA 510(k) clearance on 2021-07-01, under 510(k) number K211511.

Who is the listed applicant for decimal Bolus?

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

What is the FDA product code for decimal Bolus?

The FDA product code for decimal Bolus is MUJ.

其他以 .Decimal, LLC 為申請人之記錄

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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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