FDA 510(k)

Holter ECG and ABP system (HolterABP)

N.º K: K251591 · 2026-02-09

Fecha de decisión2026-02-09

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Holter ECG and ABP system (HolterABP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2026-02-09 under 510(k) number K251591. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Holter ECG and ABP system (HolterABP)?

Holter ECG and ABP system (HolterABP) is a medical device that received FDA 510(k) clearance on 2026-02-09. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251591.

When did Holter ECG and ABP system (HolterABP) receive FDA 510(k) clearance?

Holter ECG and ABP system (HolterABP) received FDA 510(k) clearance on 2026-02-09, under 510(k) number K251591.

Who is the listed applicant for Holter ECG and ABP system (HolterABP)?

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

What is the FDA product code for Holter ECG and ABP system (HolterABP)?

The FDA product code for Holter ECG and ABP system (HolterABP) is DQK.

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

Otros registros que enlistan a Edan Instruments, Inc. como solicitante

K251508Telemetry Monitor (iT30, iT50)K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)K241882Fetal & Maternal Monitor (F15A, F15A Air)K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)K250214Acclarix AX8 Serie Diagnóstico de Ultrasonido Sistema (Modelo: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Serie Diagnóstico de Ultrasonido Sistema (Modelo: Acclarix AX9 Básico, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)

Ver todos los 50 dispositivos →

Dispositivos relacionados (Código: DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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.