FDA 510(k)

Orfit空中床架

K 號：K200282 · 2020-04-08

決定日期2020-04-08

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

Orfit Aerial Couchtop is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K200282. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Orfit Aerial Couchtop?

Orfit Aerial Couchtop is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Orfit Industries NV. The 510(k) number is K200282.

When did Orfit Aerial Couchtop receive FDA 510(k) clearance?

Orfit Aerial Couchtop received FDA 510(k) clearance on 2020-04-08, under 510(k) number K200282.

Who is the listed applicant for Orfit Aerial Couchtop?

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

What is the FDA product code for Orfit Aerial Couchtop?

The FDA product code for Orfit Aerial Couchtop is LHN.

其他以 Orfit Industries NV 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。

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相關器械（代碼：LHN）

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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