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FDA PMA

植入式橫隔膜/胸橫隔膜神經刺激器

PMA 核准號:P860026 · 2019-11-04

決定日期2019-11-04
PMA 編號P860026
產品代碼GZE
器械分類3 類
醫療專科N
法規編號21 CFR 8
諮詢委員會AN

器材摘要

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.

常見問題

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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官方來源

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