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FDA PMA

治疗抑郁症的颅骨电疗仪

PMA编号:P230024 · 2026-07-14

决定日期2026-07-14
PMA 编号P230024
产品代码JXK
设备分类第3类
医疗专科N
法规编号21 CFR 8
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。

器械摘要

Cranial electrotherapy stimulator to treat depression is the device name listed in this FDA 510(k) record. The listed applicant is Flow Neuroscience AB. It received FDA 510(k) clearance on 2026-07-14. The device is classified under product code JXK. It was reviewed by the NE advisory panel.

常见问题

What is the Cranial electrotherapy stimulator to treat depression?

Cranial electrotherapy stimulator to treat depression is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Flow Neuroscience AB.

When did Cranial electrotherapy stimulator to treat depression receive FDA 510(k) clearance?

The clearance date for Cranial electrotherapy stimulator to treat depression can be found in the official FDA records.

Who is the listed applicant for Cranial electrotherapy stimulator to treat depression?

The FDA 510(k) record lists Flow Neuroscience AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial electrotherapy stimulator to treat depression?

The FDA product code for Cranial electrotherapy stimulator to treat depression is JXK.

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