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FDA 510(k)

Vitalograph 模型 6300 微

K 號:K160253 · 2016-08-26

決定日期2016-08-26
產品代碼BZG
諮詢委員會AN
決定相當於

器材摘要

Vitalograph Model 6300 micro is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph (Ireland) , Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K160253. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vitalograph Model 6300 micro?

Vitalograph Model 6300 micro is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Vitalograph (Ireland) , Ltd.. The 510(k) number is K160253.

When did Vitalograph Model 6300 micro receive FDA 510(k) clearance?

Vitalograph Model 6300 micro received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160253.

Who is the listed applicant for Vitalograph Model 6300 micro?

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

What is the FDA product code for Vitalograph Model 6300 micro?

The FDA product code for Vitalograph Model 6300 micro is BZG.

相關臨床試驗

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其他以 Vitalograph (Ireland) , Ltd. 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。

相關器械(代碼:BZG)

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

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