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FDA 510(k)

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

K-Number: K220917 · 2022-05-18

ApplicantGri-Alleset, Inc.
Decision Date2022-05-18
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

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 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.

Other records listing Gri-Alleset, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242664gentleheel® Adult Incision DeviceK210860Comfort Guard Mask, level 1, Comfort Guard Mask, level 3K210131ComfortGuard Surgical Isolation Gown

Related Devices (Code: FMK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.

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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