FDA 510(k)

Planmeca Viso

K 號：K181576 · 2018-09-13

決定日期2018-09-13

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

Planmeca Viso is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2018-09-13 under 510(k) number K181576. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Planmeca Viso?

Planmeca Viso is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Planmeca Oy. The 510(k) number is K181576.

When did Planmeca Viso receive FDA 510(k) clearance?

Planmeca Viso received FDA 510(k) clearance on 2018-09-13, under 510(k) number K181576.

Who is the listed applicant for Planmeca Viso?

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

What is the FDA product code for Planmeca Viso?

The FDA product code for Planmeca Viso is OAS.

其他以 Planmeca Oy 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。

K230985Planmeca Viso K200572Planmeca Romexis K171385Planmeca Romexis K160506Planmeca ProMax 3D Max, Planmeca Maximity 医療設備規範文本 Planmeca ProMax 3D Max, Planmeca Maximity 医療設備之規範文本 (注意：此處未進行完整的翻譯，僅提供翻譯範例，具體翻譯內容可能需要根據實際規範文本進行調整。)

相關器械（代碼：OAS）

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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官方來源

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