FDA 510(k)

Planmeca 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。)

K 號：K160506 · 2016-05-20

決定日期2016-05-20

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

Planmeca ProMax 3D Max, Planmeca Maximity is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160506. 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 ProMax 3D Max, Planmeca Maximity?

Planmeca ProMax 3D Max, Planmeca Maximity is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Planmeca Oy. The 510(k) number is K160506.

When did Planmeca ProMax 3D Max, Planmeca Maximity receive FDA 510(k) clearance?

Planmeca ProMax 3D Max, Planmeca Maximity received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160506.

Who is the listed applicant for Planmeca ProMax 3D Max, Planmeca Maximity?

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 ProMax 3D Max, Planmeca Maximity?

The FDA product code for Planmeca ProMax 3D Max, Planmeca Maximity is OAS.

其他以 Planmeca Oy 為申請人之記錄

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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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