FDA 510(k)

EliA 骨肋板

K 號：K202540 · 2021-09-13

決定日期2021-09-13

產品代碼MQA

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

EliA Rib-P is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K202540. The device is classified under product code MQA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EliA Rib-P?

EliA Rib-P is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Phadia AB. The 510(k) number is K202540.

When did EliA Rib-P receive FDA 510(k) clearance?

EliA Rib-P received FDA 510(k) clearance on 2021-09-13, under 510(k) number K202540.

Who is the listed applicant for EliA Rib-P?

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

What is the FDA product code for EliA Rib-P?

The FDA product code for EliA Rib-P is MQA.

其他以 Phadia AB 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253367EliA CTD 13 視窗 K212181ImmunoCAP過敏原f433，過敏原成分rTri a 14 LTP，麥，ImmunoCAP過敏原f416，過敏原成分rTri a 19 Omega-5麩質，麥，ImmunoCAP過敏原f449，過敏原成分rSes i 1 芝麻籽 K210902EliA Ro52, EliA Ro60 K202541EliA RNA Pol III 医療設備規範文本 EliA RNA Pol III 医療設備規範文本 K202067EliA SmDP-S K200279ImmunoCAP過敏原o215，成分nGal-alpha-1,3-Gal(alpha-Gal)甲状腺球蛋白，牛

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官方來源

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