FDA 510(k)

MiMo(TM) Negative Pressure Wound Therapy System

N.º K: K181929 · 2019-03-27

Fecha de decisión2019-03-27

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

MiMo(TM) Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Baymax Research, Inc.. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K181929. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MiMo(TM) Negative Pressure Wound Therapy System?

MiMo(TM) Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Baymax Research, Inc.. The 510(k) number is K181929.

When did MiMo(TM) Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

MiMo(TM) Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2019-03-27, under 510(k) number K181929.

Who is the listed applicant for MiMo(TM) Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Baymax Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiMo(TM) Negative Pressure Wound Therapy System?

The FDA product code for MiMo(TM) Negative Pressure Wound Therapy System is OMP.

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Fuente oficial

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