FDA 510(k)

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium

Número K: K240149 · 2024-06-13

RequerenteGimbo Medical Technology Shenzhen Co., Ltd.

Data da decisão2024-06-13

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium is the device name listed in this FDA 510(k) record. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K240149. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium?

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is Gimbo Medical Technology Shenzhen Co., Ltd.. The 510(k) number is K240149.

When did Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium receive FDA 510(k) clearance?

Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium received FDA 510(k) clearance on 2024-06-13, under 510(k) number K240149.

Who is the listed applicant for Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium?

The FDA 510(k) record lists Gimbo Medical Technology Shenzhen Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium?

The FDA product code for Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium is MQL.

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Outros registros que listam Gimbo Medical Technology Shenzhen Co., Ltd. como candidato(a)

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle K242043Sperm Freezing Medium K242968Giftlife® Single-Step Medium Plus K240002G-Vitri™ Vitrification Straw K234023Oocyte Flushing & Retrieval Medium; Gamete Buffer K232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media

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Dispositivos Relacionados (Código: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Fonte oficial

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