FDA 510(k)

Kitazato OPU Needles

N.º K: K162881 · 2017-07-11

Fecha de decisión2017-07-11

Código de productoMQE

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Kitazato OPU Needles is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K162881. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Kitazato OPU Needles?

Kitazato OPU Needles is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Kitazato Corporation. The 510(k) number is K162881.

When did Kitazato OPU Needles receive FDA 510(k) clearance?

Kitazato OPU Needles received FDA 510(k) clearance on 2017-07-11, under 510(k) number K162881.

Who is the listed applicant for Kitazato OPU Needles?

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

What is the FDA product code for Kitazato OPU Needles?

The FDA product code for Kitazato OPU Needles is MQE.

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Otros registros que enlistan a Kitazato Corporation como solicitante

K260248Ultra-Fast Warm K251305Ultra-Fast Vitri; Ultra-Fast Warm K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA K192845Sperm Freeze, Sperm Fridge K192540Kitazato ET Catheters

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Fuente oficial

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