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FDA 510(k)

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

K-Number: K172712 · 2017-11-06

ApplicantGri Medical & Electronic Technology Co., Ltd.
Decision Date2017-11-06
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is a medical device manufactured by Gri Medical & Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-11-06 under approval number K172712. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Gri Medical & Electronic Technology Co., Ltd.. The 510(k) number is K172712.

When was gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler approved by the FDA?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler received FDA 510(k) clearance on 2017-11-06, under approval number K172712.

What company makes gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is manufactured by Gri Medical & Electronic Technology Co., Ltd..

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.

Related Clinical Trials

NCT06587282 PREEMIE: Study for Treatment of PDA in Premature Infants ACTIVE_NOT_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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