FDA 510(k)

SonoMax系列数字彩色多普勒超声系统

K号: K233697 · 2024-08-09

申请人CHISON Medical Technologies Co., Ltd.

决定日期2024-08-09

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

SonoMax Series Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K233697. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SonoMax Series Digital Color Doppler Ultrasound System?

SonoMax Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K233697.

When did SonoMax Series Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

SonoMax Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2024-08-09, under 510(k) number K233697.

Who is the listed applicant for SonoMax Series Digital Color Doppler Ultrasound System?

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

What is the FDA product code for SonoMax Series Digital Color Doppler Ultrasound System?

The FDA product code for SonoMax Series Digital Color Doppler Ultrasound System is IYN.

列明CHISON Medical Technologies Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253949SonoPort系列数字彩色多普勒超声系统（SonoPort 1，SonoPort 1 Exp，SonoPort 1 Pro，SonoPort 1 Elite，SonoPort 1 Plus，SonoPort 2，SonoPort 2 Exp，SonoPort 2 Pro，SonoPort 2 Elite，SonoPort 2 Plus，SonoPort 3，SonoPort 3 Exp，SonoPort 3 Pro，SonoPort 3 Elite，SonoPort 3 Plus，SonoPort 4，SonoPort 4 Exp，SonoPort 4 Pro，SonoPort 4 Elite，SonoPort 4 Plus，SonoPort 5，SonoPort 5 Exp，SonoPort 5 Pro，SonoPort 5 Elite，SonoPort 5 Plus，SonoPort 6，SonoPort 6 Exp，SonoPort 6）K223570SonoAir 系列数字彩色多普勒超声系统 K202457M1 Surgical Face Mask K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G 数字彩色多普勒掌上超声系统 K201967SonoEye P2/ SonoEye V2/ SonoEye G2 数字彩色多普勒掌上超声系统 K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 数字彩色多普勒掌上超声系统

查看所有 11 个设备 →

相关器械（代码：IYN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。