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FDA 510(k)

Elde 医疗电极（T5/ 5cm x 5cm 电极 T10/ 5cm x 10cm 电极）

K号: K253237 · 2026-05-08

申请人Elde Medikal Sanayi ve Ticaret Anonim Sirketi
决定日期2026-05-08
产品代码GXY
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) is the device name listed in this FDA 510(k) record. The listed applicant is Elde Medikal Sanayi ve Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K253237. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)?

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Elde Medikal Sanayi ve Ticaret Anonim Sirketi. The 510(k) number is K253237.

When did Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) receive FDA 510(k) clearance?

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) received FDA 510(k) clearance on 2026-05-08, under 510(k) number K253237.

Who is the listed applicant for Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)?

The FDA 510(k) record lists Elde Medikal Sanayi ve Ticaret Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)?

The FDA product code for Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) is GXY.

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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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相关器械（代码：GXY）

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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官方来源

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