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FDA 510(k)

雙檢DC-1001

K 號:K212316 · 2022-09-30

決定日期2022-09-30
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

DoubleChek DC-1001 is the device name listed in this FDA 510(k) record. The listed applicant is Nasogastric Feeding Solutions, Ltd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K212316. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DoubleChek DC-1001?

DoubleChek DC-1001 is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Nasogastric Feeding Solutions, Ltd.. The 510(k) number is K212316.

When did DoubleChek DC-1001 receive FDA 510(k) clearance?

DoubleChek DC-1001 received FDA 510(k) clearance on 2022-09-30, under 510(k) number K212316.

Who is the listed applicant for DoubleChek DC-1001?

The FDA 510(k) record lists Nasogastric Feeding Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DoubleChek DC-1001?

The FDA product code for DoubleChek DC-1001 is KNT.

相關臨床試驗

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相關器械(代碼:KNT)

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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