FDA 510(k)

超流-R按鈕式血液採集套件

K 號：K220458 · 2023-09-29

申請人Innovative Medical Technologies, Inc.

決定日期2023-09-29

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

UltraFlo-R Push Button Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Medical Technologies, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K220458. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraFlo-R Push Button Blood Collection Set?

UltraFlo-R Push Button Blood Collection Set is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Innovative Medical Technologies, Inc.. The 510(k) number is K220458.

When did UltraFlo-R Push Button Blood Collection Set receive FDA 510(k) clearance?

UltraFlo-R Push Button Blood Collection Set received FDA 510(k) clearance on 2023-09-29, under 510(k) number K220458.

Who is the listed applicant for UltraFlo-R Push Button Blood Collection Set?

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

What is the FDA product code for UltraFlo-R Push Button Blood Collection Set?

The FDA product code for UltraFlo-R Push Button Blood Collection Set is JKA.

相關器械（代碼：JKA）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JKA）

官方來源