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FDA 510(k)

舒適蓋

K 號：K161920 · 2016-07-15

申請人Precision Dynamics Corporation
決定日期2016-07-15
產品代碼IZH
諮詢委員會RA
決定相當於

器材摘要

Comfort Cover is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dynamics Corporation. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161920. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Comfort Cover?

Comfort Cover is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Precision Dynamics Corporation. The 510(k) number is K161920.

When did Comfort Cover receive FDA 510(k) clearance?

Comfort Cover received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161920.

Who is the listed applicant for Comfort Cover?

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

What is the FDA product code for Comfort Cover?

The FDA product code for Comfort Cover is IZH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：IZH）

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。

K203509SMART 搜尋器Ims Giotto S.P.A.K202294Affirm 預測性切片Hologic, Inc.K191495組織切片定位器Fujifilm CorporationK161575Affirm 横向上臂切片配件HologicK153486Affirm 預防性切片系統Hologic, Inc.

官方來源

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