FDA 510(k)

XSTAT 30 袋

K 號：K210676 · 2021-08-27

決定日期2021-08-27

產品代碼PGZ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

XSTAT 30 Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Revmedx, Inc.. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210676. The device is classified under product code PGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XSTAT 30 Pouch?

XSTAT 30 Pouch is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Revmedx, Inc.. The 510(k) number is K210676.

When did XSTAT 30 Pouch receive FDA 510(k) clearance?

XSTAT 30 Pouch received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210676.

Who is the listed applicant for XSTAT 30 Pouch?

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

What is the FDA product code for XSTAT 30 Pouch?

The FDA product code for XSTAT 30 Pouch is PGZ.

其他以 Revmedx, Inc. 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。

K253290XSTAT P15 K180051XSTAT 30, 1入包 K170334XSTAT 30，3入包；XSTAT 30，1入包；XSTAT 12，3包；XSTAT 12，1包 K161020XSTAT-12，3入包，XSTAT-12，1入包

相關器械（代碼：PGZ）

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。

K253290XSTAT P15Revmedx, Inc.K180051XSTAT 30, 1入包Revmedx, Inc.K170334XSTAT 30，3入包；XSTAT 30，1入包；XSTAT 12，3包；XSTAT 12，1包Revmedx, Inc.K161020XSTAT-12，3入包，XSTAT-12，1入包Revmedx, Inc.

官方來源

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