FDA 510(k)

沙哈拉穩定系統

K 號：K190179 · 2019-10-03

決定日期2019-10-03

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

SAHARA Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K190179. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SAHARA Stabilization System?

SAHARA Stabilization System is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is K2m, Inc.. The 510(k) number is K190179.

When did SAHARA Stabilization System receive FDA 510(k) clearance?

SAHARA Stabilization System received FDA 510(k) clearance on 2019-10-03, under 510(k) number K190179.

Who is the listed applicant for SAHARA Stabilization System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAHARA Stabilization System?

The FDA product code for SAHARA Stabilization System is OVD.

其他以 K2m, Inc. 為申請人之記錄

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相關器械（代碼：OVD）

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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