FDA 510(k)

Prospera Spectruum Negative Pressure Wound Therapy System

Número K: K230233 · 2024-04-18

Data da decisão2024-04-18

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Prospera Spectruum Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K230233. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Prospera Spectruum Negative Pressure Wound Therapy System?

Prospera Spectruum Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K230233.

When did Prospera Spectruum Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

Prospera Spectruum Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2024-04-18, under 510(k) number K230233.

Who is the listed applicant for Prospera Spectruum Negative Pressure Wound Therapy System?

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

What is the FDA product code for Prospera Spectruum Negative Pressure Wound Therapy System?

The FDA product code for Prospera Spectruum Negative Pressure Wound Therapy System is OMP.

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Fonte oficial

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