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FDA 510(k)

CloudHRV™ System (100-01-001)

K-Number: K241217 · 2025-01-16

ApplicantInmedix, Inc.
Decision Date2025-01-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Inmedix, Inc.. The 510(k) number is K241217.

When was CloudHRV™ System (100-01-001) approved by the FDA?

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

What company makes CloudHRV™ System (100-01-001)?

CloudHRV™ System (100-01-001) is manufactured by Inmedix, Inc..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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