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FDA 510(k)

導向米亞正骨科+

K 號：K162850 · 2017-03-24

申請人Guidemia Technologies, LLC
決定日期2017-03-24
產品代碼PNN
諮詢委員會DE
決定相當於

器材摘要

GuideMia Ortho+ is the device name listed in this FDA 510(k) record. The listed applicant is Guidemia Technologies, LLC. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162850. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GuideMia Ortho+?

GuideMia Ortho+ is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Guidemia Technologies, LLC. The 510(k) number is K162850.

When did GuideMia Ortho+ receive FDA 510(k) clearance?

GuideMia Ortho+ received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162850.

Who is the listed applicant for GuideMia Ortho+?

The FDA 510(k) record lists Guidemia Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GuideMia Ortho+?

The FDA product code for GuideMia Ortho+ is PNN.

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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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