FDA 510(k)

ScanX 隔離信封

K 號：K190949 · 2019-07-26

決定日期2019-07-26

產品代碼PEM

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

ScanX Barrier Envelopes is the device name listed in this FDA 510(k) record. The listed applicant is Air Techniques, Inc.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K190949. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ScanX Barrier Envelopes?

ScanX Barrier Envelopes is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Air Techniques, Inc.. The 510(k) number is K190949.

When did ScanX Barrier Envelopes receive FDA 510(k) clearance?

ScanX Barrier Envelopes received FDA 510(k) clearance on 2019-07-26, under 510(k) number K190949.

Who is the listed applicant for ScanX Barrier Envelopes?

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

What is the FDA product code for ScanX Barrier Envelopes?

The FDA product code for ScanX Barrier Envelopes is PEM.

其他以 Air Techniques, 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。

K191623ScanX Touch/ScanX Duo Touch

相關器械（代碼：PEM）

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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