FDA 510(k)

Ultra RapidWarm™ Hachazo

N.º K: K240605 · 2024-08-07

Fecha de decisión2024-08-07

Código de productoMQL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ultra RapidWarm™ Blast is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2024-08-07 under 510(k) number K240605. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ultra RapidWarm™ Blast?

Ultra RapidWarm™ Blast is a medical device that received FDA 510(k) clearance on 2024-08-07. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K240605.

When did Ultra RapidWarm™ Blast receive FDA 510(k) clearance?

Ultra RapidWarm™ Blast received FDA 510(k) clearance on 2024-08-07, under 510(k) number K240605.

Who is the listed applicant for Ultra RapidWarm™ Blast?

The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultra RapidWarm™ Blast?

The FDA product code for Ultra RapidWarm™ Blast is MQL.

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Otros registros que enlistan a Vitrolife Sweden AB como solicitante

K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)K241662Ultrasound Transducer Cover K202862Gx-IVF, Gx-TL, Gx-MOPS PLUS K183486RapidVit™ Oocyte, RapidWarm™ Oocyte K181461Rapid-i™ Kit K172050Follicle Aspiration Set, Reduced Single Lumen

Ver todos los 8 dispositivos →

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

Fuente oficial

Ver en la base de datos de la FDA →

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