FDA 510(k)

SE-1202系列心电图机（型号：SE-1202，SE-1202E）

K号: K252463 · 2026-07-02

决定日期2026-07-02

产品代码DPS

咨询委员会CV

决定Substantially Equivalent

器械摘要

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) 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 2026-07-02 under 510(k) number K252463. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)?

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K252463.

When did SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) receive FDA 510(k) clearance?

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) received FDA 510(k) clearance on 2026-07-02, under 510(k) number K252463.

Who is the listed applicant for SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)?

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 SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)?

The FDA product code for SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) is DPS.

列明Edan Instruments, Inc.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。

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