FDA 510(k)

Gem Flow Now (GEM2770-FN)

K号: K233394 · 2024-01-28

决定日期2024-01-28

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Gem Flow Now (GEM2770-FN) is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Micro Companies Alliance. It received FDA 510(k) clearance on 2024-01-28 under 510(k) number K233394. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gem Flow Now (GEM2770-FN)?

Gem Flow Now (GEM2770-FN) is a medical device that received FDA 510(k) clearance on 2024-01-28. The listed applicant is Synovis Micro Companies Alliance. The 510(k) number is K233394.

When did Gem Flow Now (GEM2770-FN) receive FDA 510(k) clearance?

Gem Flow Now (GEM2770-FN) received FDA 510(k) clearance on 2024-01-28, under 510(k) number K233394.

Who is the listed applicant for Gem Flow Now (GEM2770-FN)?

The FDA 510(k) record lists Synovis Micro Companies Alliance as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gem Flow Now (GEM2770-FN)?

The FDA product code for Gem Flow Now (GEM2770-FN) is IYN.

相关器械（代码：IYN）

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