免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

PainTB, PainTJ

K 號：K203337 · 2022-02-11

申請人Ptech Co., Ltd.
決定日期2022-02-11
產品代碼NHN
諮詢委員會PM
決定相當於

器材摘要

PainTB, PainTJ is the device name listed in this FDA 510(k) record. The listed applicant is Ptech Co., Ltd.. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K203337. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PainTB, PainTJ?

PainTB, PainTJ is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Ptech Co., Ltd.. The 510(k) number is K203337.

When did PainTB, PainTJ receive FDA 510(k) clearance?

PainTB, PainTJ received FDA 510(k) clearance on 2022-02-11, under 510(k) number K203337.

Who is the listed applicant for PainTB, PainTJ?

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

What is the FDA product code for PainTB, PainTJ?

The FDA product code for PainTB, PainTJ is NHN.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：NHN）

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。

K254024MR5 活動專業版Multi Radiance Medical, Inc.K251903Erchonia DPN雷射（型號# EVRL）Erchonia CorporationK252273治療美國Dmc Importação E Exportação DE Equipamentos LtdaK241057強化手持式疼痛緩解雷射儀器（GD-P-E）Wuhan Guangdun Technology Co.,Ltd..K232813治療EC，治療XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

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。

↑