FDA 510(k)

CloudHRV™ System (100-01-001)

K-Number: K241217 · 2025-01-16

Decision Date2025-01-16

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial K243252ZBPro DiagnosticZbeats, Inc.

Official Source

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