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FDA 510(k)

Resmon PRO FULL

K号: K152585 · 2016-06-24

申请人Medical Graphics Corp.
决定日期2016-06-24
产品代码PNV
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决定实质等同

器械摘要

Resmon PRO FULL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Graphics Corp.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K152585. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Resmon PRO FULL?

Resmon PRO FULL is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Medical Graphics Corp.. The 510(k) number is K152585.

When did Resmon PRO FULL receive FDA 510(k) clearance?

Resmon PRO FULL received FDA 510(k) clearance on 2016-06-24, under 510(k) number K152585.

Who is the listed applicant for Resmon PRO FULL?

The FDA 510(k) record lists Medical Graphics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resmon PRO FULL?

The FDA product code for Resmon PRO FULL is PNV.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：PNV）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K221024Tremoflo C2 Airwave 振动描记系统Thorasys Thoracic Medical Systems, Inc.K191876PulmoScanCognita Labs, LLCK170185tremoFlo C-100 空气波振荡测量系统Thorasys Thoracic Medical Systems, Inc.

官方来源

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