FDA 510(k)

疼痛治疗系统，型号PTS-II

K号: K150277 · 2016-02-12

申请人Counter Scientific Development (Gz), Ltd.

决定日期2016-02-12

产品代码NUH

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决定实质等同

器械摘要

Pain Therapy System, Model PTS-II is the device name listed in this FDA 510(k) record. The listed applicant is Counter Scientific Development (Gz), Ltd.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K150277. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pain Therapy System, Model PTS-II?

Pain Therapy System, Model PTS-II is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Counter Scientific Development (Gz), Ltd.. The 510(k) number is K150277.

When did Pain Therapy System, Model PTS-II receive FDA 510(k) clearance?

Pain Therapy System, Model PTS-II received FDA 510(k) clearance on 2016-02-12, under 510(k) number K150277.

Who is the listed applicant for Pain Therapy System, Model PTS-II?

The FDA 510(k) record lists Counter Scientific Development (Gz), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pain Therapy System, Model PTS-II?

The FDA product code for Pain Therapy System, Model PTS-II is NUH.

列明Counter Scientific Development (Gz), Ltd.为申报人的其他记录

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。

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