Z機械 協調
K 號：K172986 · 2017-12-19
廣告
決定日期2017-12-19
產品代碼OLV
諮詢委員會NE
(請提供完整的英文描述，以便進行翻譯。)
決定相當於
器材摘要
Zmachine Synergy is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Research of Richmond, Inc. Dba General Sleep CO. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K172986. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Zmachine Synergy?
Zmachine Synergy is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Consolidated Research of Richmond, Inc. Dba General Sleep CO. The 510(k) number is K172986.
When did Zmachine Synergy receive FDA 510(k) clearance?
Zmachine Synergy received FDA 510(k) clearance on 2017-12-19, under 510(k) number K172986.
Who is the listed applicant for Zmachine Synergy?
The FDA 510(k) record lists Consolidated Research of Richmond, Inc. Dba General Sleep CO as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zmachine Synergy?
The FDA product code for Zmachine Synergy is OLV.
相關臨床試驗
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相關器械（代碼：OLV）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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