OW100S（型號 OW100S-US）
K 號：K213120 · 2022-10-12
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器材摘要
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.
常見問題
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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相關器械（代碼：ISA）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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