FDA 510(k)

Prospera Spectruum负压伤口治疗黑色泡沫套件和白色泡沫附件

K号: K250586 · 2025-11-21

决定日期2025-11-21

产品代码OMP

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决定实质等同

器械摘要

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory 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 2025-11-21 under 510(k) number K250586. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K250586.

When did Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory receive FDA 510(k) clearance?

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory received FDA 510(k) clearance on 2025-11-21, under 510(k) number K250586.

Who is the listed applicant for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory?

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 Black Foam Kits and White Foam Accessory?

The FDA product code for Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory is OMP.

列明Deroyal Industries, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230233Prospera Spectruum负压伤口治疗系统 K200631DeRoyal 温度监测探头 K200757Foley 带温度传感器的导管 K200319HYDRO-TEMP新生儿皮肤表面温度传感器，HYDRO-TEMP新生儿皮肤表面温度传感器带接口线 K193027食管听诊器 9 法寸，食管听诊器 12 法寸，食管听诊器 18 法寸，食管听诊器，24 法寸 K191425Hydro-Temp 新生儿皮肤温度探头盖

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官方来源

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