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: K172712 · 2017-11-06

申請者Gri Medical & Electronic Technology Co., Ltd.

決定日2017-11-06

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 Medical & Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-11-06 under 510(k) number K172712. 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 2017-11-06. The listed applicant is Gri Medical & Electronic Technology Co., Ltd.. The 510(k) number is K172712.

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 2017-11-06, under 510(k) number K172712.

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

The FDA 510(k) record lists Gri Medical & Electronic Technology Co., Ltd. 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 Medical & Electronic Technology Co., Ltd.を記載するその他の記録

K172835GRI-Alleset 補充針

公式ソース

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