FDA 510(k)

ComPAS2

K 號：K213872 · 2022-07-15

決定日期2022-07-15

產品代碼BZG

諮詢委員會AN

決定相當於

器材摘要

ComPAS2 is the device name listed in this FDA 510(k) record. The listed applicant is Morgan Scientific, Inc.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K213872. 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 ComPAS2?

ComPAS2 is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Morgan Scientific, Inc.. The 510(k) number is K213872.

When did ComPAS2 receive FDA 510(k) clearance?

ComPAS2 received FDA 510(k) clearance on 2022-07-15, under 510(k) number K213872.

Who is the listed applicant for ComPAS2?

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

What is the FDA product code for ComPAS2?

The FDA product code for ComPAS2 is BZG.

其他以 Morgan Scientific, Inc. 為申請人之記錄

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K190568ComPAS2（電腦肺功能分析系統）

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。

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