FDA 510(k)

VenAir，連續壓縮系統

K 號：K213577 · 2022-06-28

決定日期2022-06-28

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

VenAir, Sequential Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K213577. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VenAir, Sequential Compression System?

VenAir, Sequential Compression System is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Apex Medical Corp.. The 510(k) number is K213577.

When did VenAir, Sequential Compression System receive FDA 510(k) clearance?

VenAir, Sequential Compression System received FDA 510(k) clearance on 2022-06-28, under 510(k) number K213577.

Who is the listed applicant for VenAir, Sequential Compression System?

The FDA 510(k) record lists Apex Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VenAir, Sequential Compression System?

The FDA product code for VenAir, Sequential Compression System is JOW.

其他以 Apex Medical Corp. 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。

K193206WiZARD 510 鼻罩 K182394WiZARD 310/320系列CPAP口罩

相關器械（代碼：JOW）

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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