FDA 510(k)

MY01 持續隔間壓力監測器

K 號：K210525 · 2021-04-22

決定日期2021-04-22

產品代碼LXC

決定相當於

器材摘要

MY01 Continuous Compartmental Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is MY01, Inc.. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K210525. The device is classified under product code LXC. FDA Decision: Substantially Equivalent.

常見問題

What is the MY01 Continuous Compartmental Pressure Monitor?

MY01 Continuous Compartmental Pressure Monitor is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is MY01, Inc.. The 510(k) number is K210525.

When did MY01 Continuous Compartmental Pressure Monitor receive FDA 510(k) clearance?

MY01 Continuous Compartmental Pressure Monitor received FDA 510(k) clearance on 2021-04-22, under 510(k) number K210525.

Who is the listed applicant for MY01 Continuous Compartmental Pressure Monitor?

The FDA 510(k) record lists MY01, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MY01 Continuous Compartmental Pressure Monitor?

The FDA product code for MY01 Continuous Compartmental Pressure Monitor is LXC.

其他以 MY01, 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。

K251900MY01 持續隔間壓力監測器 K242997MY01 持續隔間壓力監測器 K220952MY01 持續隔間壓力監測器 K202635MY01 持續隔間壓力監測器 K193321MY01 持續隔間壓力監測器

相關器械（代碼：LXC）

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。

K251900MY01 持續隔間壓力監測器MY01, Inc.K242997MY01 持續隔間壓力監測器MY01, Inc.K223509Compremium 製品隔間壓縮性監測系統（CPM#1）Compremium AG K220952MY01 持續隔間壓力監測器MY01, Inc.K202635MY01 持續隔間壓力監測器MY01, Inc.K193321MY01 持續隔間壓力監測器MY01, Inc.

官方來源

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