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FDA 510(k)

Isopure乾式酸溶系統

K 號：K191093 · 2020-01-22

申請人Isopure, Corp.
決定日期2020-01-22
產品代碼KPO
諮詢委員會GU
決定相當於

器材摘要

Isopure Dry Acid Dissolution System is the device name listed in this FDA 510(k) record. The listed applicant is Isopure, Corp.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K191093. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Isopure Dry Acid Dissolution System?

Isopure Dry Acid Dissolution System is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Isopure, Corp.. The 510(k) number is K191093.

When did Isopure Dry Acid Dissolution System receive FDA 510(k) clearance?

Isopure Dry Acid Dissolution System received FDA 510(k) clearance on 2020-01-22, under 510(k) number K191093.

Who is the listed applicant for Isopure Dry Acid Dissolution System?

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

What is the FDA product code for Isopure Dry Acid Dissolution System?

The FDA product code for Isopure Dry Acid Dissolution System is KPO.

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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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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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