FDA 510(k)

DIVA ZSP2105CMI 配合 QUBYX PerfectLum 套件

K 號：K160328 · 2016-02-25

決定日期2016-02-25

產品代碼PGY

諮詢委員會RA

決定相當於

器材摘要

DIVA ZSP2105CMI with QUBYX PerfectLum bundle is the device name listed in this FDA 510(k) record. The listed applicant is The Linden Group Corp. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K160328. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DIVA ZSP2105CMI with QUBYX PerfectLum bundle?

DIVA ZSP2105CMI with QUBYX PerfectLum bundle is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is The Linden Group Corp. The 510(k) number is K160328.

When did DIVA ZSP2105CMI with QUBYX PerfectLum bundle receive FDA 510(k) clearance?

DIVA ZSP2105CMI with QUBYX PerfectLum bundle received FDA 510(k) clearance on 2016-02-25, under 510(k) number K160328.

Who is the listed applicant for DIVA ZSP2105CMI with QUBYX PerfectLum bundle?

The FDA 510(k) record lists The Linden Group Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIVA ZSP2105CMI with QUBYX PerfectLum bundle?

The FDA product code for DIVA ZSP2105CMI with QUBYX PerfectLum bundle is PGY.

其他以 The Linden Group Corp 為申請人之記錄

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相關器械（代碼：PGY）

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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