FDA 510(k)

Medispine - 脊椎穿刺针，Glospine - 脊椎穿刺针

K号: K212982 · 2022-07-29

决定日期2022-07-29

产品代码BSP

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决定实质等同

器械摘要

Medispine - Spinal Needle, Glospine - Spinal Needle is the device name listed in this FDA 510(k) record. The listed applicant is Global Medikit Limited. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K212982. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medispine - Spinal Needle, Glospine - Spinal Needle?

Medispine - Spinal Needle, Glospine - Spinal Needle is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Global Medikit Limited. The 510(k) number is K212982.

When did Medispine - Spinal Needle, Glospine - Spinal Needle receive FDA 510(k) clearance?

Medispine - Spinal Needle, Glospine - Spinal Needle received FDA 510(k) clearance on 2022-07-29, under 510(k) number K212982.

Who is the listed applicant for Medispine - Spinal Needle, Glospine - Spinal Needle?

The FDA 510(k) record lists Global Medikit Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medispine - Spinal Needle, Glospine - Spinal Needle?

The FDA product code for Medispine - Spinal Needle, Glospine - Spinal Needle is BSP.

列明Global Medikit Limited为申报人的其他记录

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