FDA 510(k)

嵌入式醫療設備

K 號：K221943 · 2023-02-01

決定日期2023-02-01

產品代碼PBF

諮詢委員會或

決定相當於

器材摘要

EmbedMed is the device name listed in this FDA 510(k) record. The listed applicant is 3D Lifeprints UK , Ltd.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K221943. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EmbedMed?

EmbedMed is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is 3D Lifeprints UK , Ltd.. The 510(k) number is K221943.

When did EmbedMed receive FDA 510(k) clearance?

EmbedMed received FDA 510(k) clearance on 2023-02-01, under 510(k) number K221943.

Who is the listed applicant for EmbedMed?

The FDA 510(k) record lists 3D Lifeprints UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EmbedMed?

The FDA product code for EmbedMed is PBF.

其他以 3D Lifeprints UK , Ltd. 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。

K220366嵌入式醫療設備

相關器械（代碼：PBF）

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。

K252064MedCAD® AccuStride™ 系統Medcad K250711VSP骨科系統3D Systems, Inc.K242603MyPAO SA 指導Medacta International S.A.K251709MedCAD® AccuStride™ 系統Medcad K250394精細TTO™Bodycad Laboratories, Inc.K250767Newclip 患者匹配儀器非無菌 PSINewclip Technics

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。