FDA 510(k)

AirStrip RPM InvisionHeart適配器

K 號：K182226 · 2018-09-11

決定日期2018-09-11

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

AirStrip RPM InvisionHeart Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Airstrip Technologies, Inc.. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K182226. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AirStrip RPM InvisionHeart Adapter?

AirStrip RPM InvisionHeart Adapter is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Airstrip Technologies, Inc.. The 510(k) number is K182226.

When did AirStrip RPM InvisionHeart Adapter receive FDA 510(k) clearance?

AirStrip RPM InvisionHeart Adapter received FDA 510(k) clearance on 2018-09-11, under 510(k) number K182226.

Who is the listed applicant for AirStrip RPM InvisionHeart Adapter?

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

What is the FDA product code for AirStrip RPM InvisionHeart Adapter?

The FDA product code for AirStrip RPM InvisionHeart Adapter is MWI.

其他以 Airstrip Technologies, 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。

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相關器械（代碼：MWI）

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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