FDA 510(k)

SONON Ultrasound Imaging System, Model: 300L

N.º K: K170085 · 2017-10-12

Fecha de decisión2017-10-12

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

SONON Ultrasound Imaging System, Model: 300L is the device name listed in this FDA 510(k) record. The listed applicant is Healcerion Co., Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170085. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SONON Ultrasound Imaging System, Model: 300L?

SONON Ultrasound Imaging System, Model: 300L is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Healcerion Co., Ltd.. The 510(k) number is K170085.

When did SONON Ultrasound Imaging System, Model: 300L receive FDA 510(k) clearance?

SONON Ultrasound Imaging System, Model: 300L received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170085.

Who is the listed applicant for SONON Ultrasound Imaging System, Model: 300L?

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

What is the FDA product code for SONON Ultrasound Imaging System, Model: 300L?

The FDA product code for SONON Ultrasound Imaging System, Model: 300L is IYN.

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 Healcerion Co., Ltd. como solicitante

K211665SONON Ultrasound Imaging System, Model: SONON300C K212400SONON Ultrasound Imaging System, Model: SONON 500L

Dispositivos relacionados (Código: IYN)

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.