FDA 510(k)

VSP頭部系統

K 號：K151285 · 2016-09-23

決定日期2016-09-23

產品代碼PPT

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

VSP Cranial System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems, Inc.. It received FDA 510(k) clearance on 2016-09-23 under 510(k) number K151285. The device is classified under product code PPT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VSP Cranial System?

VSP Cranial System is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is 3D Systems, Inc.. The 510(k) number is K151285.

When did VSP Cranial System receive FDA 510(k) clearance?

VSP Cranial System received FDA 510(k) clearance on 2016-09-23, under 510(k) number K151285.

Who is the listed applicant for VSP Cranial System?

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

What is the FDA product code for VSP Cranial System?

The FDA product code for VSP Cranial System is PPT.

其他以 3D Systems, Inc. 為申請人之記錄

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K261826VSP系統（鈦金顎板牙橋）K250711VSP骨科系統 K243174Cadence 腳踝壓力測量系統 K243173Salto Talaris 腓骨踝壓力系統 K241326Cadence 腳踝壓力測量系統 K241148Salto Talaris 腓骨踝壓力系統

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相關器械（代碼：PPT）

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。

K253308Materialise 頭顎面外科手術個人化導引和模型 CMF 鋼钛導引；CMF 塑膠模型Materialise NV K201052KLS Martin 個人病人解決方案（IPS）規劃系統KLS-Martin L.P.K182889KLS Martin 個人病人解決方案（IPS）規劃系統KLS-Martin L.P.

官方來源

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