FDA 510(k)

CloudHRV™ System (100-01-001)

Número K: K241217 · 2025-01-16

Data da decisão2025-01-16

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CloudHRV™ System (100-01-001) is the device name listed in this FDA 510(k) record. The listed applicant is Inmedix, Inc.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K241217. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CloudHRV™ System (100-01-001)?

CloudHRV™ System (100-01-001) is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Inmedix, Inc.. The 510(k) number is K241217.

When did CloudHRV™ System (100-01-001) receive FDA 510(k) clearance?

CloudHRV™ System (100-01-001) received FDA 510(k) clearance on 2025-01-16, under 510(k) number K241217.

Who is the listed applicant for CloudHRV™ System (100-01-001)?

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

What is the FDA product code for CloudHRV™ System (100-01-001)?

The FDA product code for CloudHRV™ System (100-01-001) is DPS.

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