FDA 510(k)

CloudHRV™ System (100-01-001)

N.º K: K241217 · 2025-01-16

Fecha de decisión2025-01-16

Código de productoDPS

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: DPS)

K254255S-Patch CardioAIWellysis Corp.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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.