FDA 510(k)

gentleheel 微早產兒，gentleheel 早產兒，gentleheel 新生兒，gentleheel 幼兒

K 號：K220917 · 2022-05-18

決定日期2022-05-18

產品代碼FMK

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

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is the device name listed in this FDA 510(k) record. The listed applicant is Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2022-05-18 under 510(k) number K220917. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is a medical device that received FDA 510(k) clearance on 2022-05-18. The listed applicant is Gri-Alleset, Inc.. The 510(k) number is K220917.

When did gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler receive FDA 510(k) clearance?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler received FDA 510(k) clearance on 2022-05-18, under 510(k) number K220917.

Who is the listed applicant for gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler?

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

What is the FDA product code for gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler?

The FDA product code for gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is FMK.

其他以 Gri-Alleset, Inc. 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。

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相關器械（代碼：FMK）

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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