FDA 510(k)

OW100S (model OW100S-US)

K-번호: K213120 · 2022-10-12

신청자Tissue Regeneration Technologies, LLC Dba AS Softwave Trt

결정일2022-10-12

제품 코드ISA

자문 위원회PM

결정Substantially Equivalent

기기 요약

OW100S (model OW100S-US) is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K213120. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the OW100S (model OW100S-US)?

OW100S (model OW100S-US) is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. The 510(k) number is K213120.

When did OW100S (model OW100S-US) receive FDA 510(k) clearance?

OW100S (model OW100S-US) received FDA 510(k) clearance on 2022-10-12, under 510(k) number K213120.

Who is the listed applicant for OW100S (model OW100S-US)?

The FDA 510(k) record lists Tissue Regeneration Technologies, LLC Dba AS Softwave Trt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OW100S (model OW100S-US)?

The FDA product code for OW100S (model OW100S-US) is ISA.

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OW100S (model OW100S-US)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: ISA)

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