免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

OmniVersa 多模态治疗系统及 Omnistim FX2 专业治疗系统

K号: K153559 · 2016-08-26

决定日期2016-08-26
产品代码IMG
咨询委员会PM 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Care Plus (Acp). It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K153559. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System?

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Accelerated Care Plus (Acp). The 510(k) number is K153559.

When did OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System receive FDA 510(k) clearance?

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System received FDA 510(k) clearance on 2016-08-26, under 510(k) number K153559.

Who is the listed applicant for OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System?

The FDA 510(k) record lists Accelerated Care Plus (Acp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System?

The FDA product code for OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System is IMG.

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。

相关器械(代码:IMG)

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。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

↑