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FDA 510(k)

Diversatek Healthcare 高解析阻抗測量法探針 (HRiM)

K 號：K190208 · 2019-10-03

申請人Diversatek Healthcare
決定日期2019-10-03
產品代碼FFX
諮詢委員會GU
決定相當於

器材摘要

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is the device name listed in this FDA 510(k) record. The listed applicant is Diversatek Healthcare. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K190208. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe?

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Diversatek Healthcare. The 510(k) number is K190208.

When did Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe receive FDA 510(k) clearance?

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe received FDA 510(k) clearance on 2019-10-03, under 510(k) number K190208.

Who is the listed applicant for Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe?

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

What is the FDA product code for Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe?

The FDA product code for Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is FFX.

相關臨床試驗

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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其他以 Diversatek Healthcare 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。

K230056MiVu™ 食管內視鏡帽K222734Diversatek Healthcare PureFlo 灌洗系統 / 水壺管路

相關器械（代碼：FFX）

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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