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FDA PMA

植入式膈神经/横膈神经刺激器

PMA编号:P860026 · 2019-11-04

决定日期2019-11-04
PMA 编号P860026
产品代码GZE
设备分类第3类
医疗专科N
法规编号21 CFR 8
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。

器械摘要

implanted diaphragmatic/phrenic nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Avery Biomedical Devices, Inc.. It received FDA 510(k) clearance on 2019-11-04. The device is classified under product code GZE. It was reviewed by the AN advisory panel.

常见问题

What is the implanted diaphragmatic/phrenic nerve Stimulator?

implanted diaphragmatic/phrenic nerve Stimulator is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Avery Biomedical Devices, Inc..

When did implanted diaphragmatic/phrenic nerve Stimulator receive FDA 510(k) clearance?

The clearance date for implanted diaphragmatic/phrenic nerve Stimulator can be found in the official FDA records.

Who is the listed applicant for implanted diaphragmatic/phrenic nerve Stimulator?

The FDA 510(k) record lists Avery Biomedical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for implanted diaphragmatic/phrenic nerve Stimulator?

The FDA product code for implanted diaphragmatic/phrenic nerve Stimulator is GZE.

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