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FDA 510(k)

頭顱顏面固定系統 (CMF) - CMF Visionare

K 號：K180204 · 2018-12-28

申請人Visionare, LLC
決定日期2018-12-28
產品代碼JEY
諮詢委員會DE
決定相當於

器材摘要

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is the device name listed in this FDA 510(k) record. The listed applicant is Visionare, LLC. It received FDA 510(k) clearance on 2018-12-28 under 510(k) number K180204. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is a medical device that received FDA 510(k) clearance on 2018-12-28. The listed applicant is Visionare, LLC. The 510(k) number is K180204.

When did CranioMaxillofacial Fixation (CMF) System - CMF Visionare receive FDA 510(k) clearance?

CranioMaxillofacial Fixation (CMF) System - CMF Visionare received FDA 510(k) clearance on 2018-12-28, under 510(k) number K180204.

Who is the listed applicant for CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

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

What is the FDA product code for CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

The FDA product code for CranioMaxillofacial Fixation (CMF) System - CMF Visionare is JEY.

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