FDA 510(k)

BD 骨髓内血管通路系统 EMS 驱动器 (D001003)

K号: K223198 · 2022-11-10

决定日期2022-11-10

产品代码MHC

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决定实质等同

器械摘要

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K223198. The device is classified under product code MHC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Bard Access Systems. The 510(k) number is K223198.

When did BD Intraosseous Vascular Access System EMS Powered Driver (D001003) receive FDA 510(k) clearance?

BD Intraosseous Vascular Access System EMS Powered Driver (D001003) received FDA 510(k) clearance on 2022-11-10, under 510(k) number K223198.

Who is the listed applicant for BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

The FDA 510(k) record lists Bard Access Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Intraosseous Vascular Access System EMS Powered Driver (D001003)?

The FDA product code for BD Intraosseous Vascular Access System EMS Powered Driver (D001003) is MHC.

官方来源

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BD 骨髓内血管通路系统 EMS 驱动器 (D001003)

器械摘要

常见问题

相关临床试验

相关器械（代码：MHC）

官方来源