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FDA PMA

設備,陽痿,機械/水壓

PMA 核准號:P000006 · 2026-08-13

決定日期2026-08-13
PMA 編號P000006
產品代碼FHW
器械分類3 類
醫療專科G
法規編號21 CFR 8
諮詢委員會GU

器材摘要

Device, impotence, mechanical/hydraulic is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2026-08-13. The device is classified under product code FHW. It was reviewed by the GU advisory panel.

常見問題

What is the Device, impotence, mechanical/hydraulic?

Device, impotence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Coloplast Corp..

When did Device, impotence, mechanical/hydraulic receive FDA 510(k) clearance?

The clearance date for Device, impotence, mechanical/hydraulic can be found in the official FDA records.

誰是設備、陽痿、機械/水壓的登記申請人?

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

FDA產品代碼為設備、陽痿、機械/水壓的代碼是什麼?

FDA產品代碼對於設備、陽痿、機械/水壓類為FHW。

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官方來源

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