FDA 510(k)

電子足部X光系統 HF

K 號：K180765 · 2018-04-20

決定日期2018-04-20

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

Televere Podiatry X-Ray System HF is the device name listed in this FDA 510(k) record. The listed applicant is Televere Systems, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180765. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Televere Podiatry X-Ray System HF?

Televere Podiatry X-Ray System HF is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Televere Systems, Inc.. The 510(k) number is K180765.

When did Televere Podiatry X-Ray System HF receive FDA 510(k) clearance?

Televere Podiatry X-Ray System HF received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180765.

Who is the listed applicant for Televere Podiatry X-Ray System HF?

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

What is the FDA product code for Televere Podiatry X-Ray System HF?

The FDA product code for Televere Podiatry X-Ray System HF is KPR.

其他以 Televere Systems, Inc. 為申請人之記錄

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K181358電子牙科影像系統

相關器械（代碼：KPR）

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。

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