FDA 510(k)

疼痛治療系統，型號 PTS-II

K 號：K150277 · 2016-02-12

申請人Counter Scientific Development (Gz), Ltd.

決定日期2016-02-12

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Counter Scientific Development (Gz), Ltd. 為申請人之記錄

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