FDA 510(k)

gentleheel 微小早产儿，gentleheel 早产儿，gentleheel 新生儿，gentleheel 婴儿

K号: K172712 · 2017-11-06

申请人Gri Medical & Electronic Technology Co., Ltd.

决定日期2017-11-06

产品代码FMK

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决定实质等同

器械摘要

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 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.

常见问题

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.

列明Gri Medical & Electronic Technology Co., Ltd.为申报人的其他记录

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K172835GRI-Alleset Veress 针

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