FDA 510(k)

ALTMS 磁刺激治疗系统，Blossom TMS 治疗系统

K号: K220625 · 2022-04-06

决定日期2022-04-06

产品代码OBP

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决定实质等同

器械摘要

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Remed Co., Ltd.. It received FDA 510(k) clearance on 2022-04-06 under 510(k) number K220625. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System?

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Remed Co., Ltd.. The 510(k) number is K220625.

When did ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System receive FDA 510(k) clearance?

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System received FDA 510(k) clearance on 2022-04-06, under 510(k) number K220625.

Who is the listed applicant for ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System?

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

What is the FDA product code for ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System?

The FDA product code for ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System is OBP.

列明Remed Co., Ltd.为申报人的其他记录

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K202537ALTMS 磁刺激治疗系统 K202031Talent-Pro 电刺激器

官方来源

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