FDA 510(k)

Medsynapse Ris Pacs & Medsynapse VNA

K号: K192508 · 2019-11-22

决定日期2019-11-22

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Medsynapse Ris Pacs & Medsynapse VNA is the device name listed in this FDA 510(k) record. The listed applicant is Medsynaptic Private, Ltd.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K192508. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medsynapse Ris Pacs & Medsynapse VNA?

Medsynapse Ris Pacs & Medsynapse VNA is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Medsynaptic Private, Ltd.. The 510(k) number is K192508.

When did Medsynapse Ris Pacs & Medsynapse VNA receive FDA 510(k) clearance?

Medsynapse Ris Pacs & Medsynapse VNA received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192508.

Who is the listed applicant for Medsynapse Ris Pacs & Medsynapse VNA?

The FDA 510(k) record lists Medsynaptic Private, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medsynapse Ris Pacs & Medsynapse VNA?

The FDA product code for Medsynapse Ris Pacs & Medsynapse VNA is LLZ.

列明Medsynaptic Private, Ltd.为申报人的其他记录

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