FDA 510(k)

gentleheel マイクロプレミー、gentleheel プレミー、gentleheel ニューボーン、gentleheel トダラー

K番号: K220917 · 2022-05-18

決定日2022-05-18

製品コードFMK

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてGri-Alleset, Inc.を記載するその他の記録

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