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FDA 510(k)

數 Vapocoolant

K 號：K202782 · 2020-12-21

申請人623 Medical, LLC
決定日期2020-12-21
產品代碼MLY
決定相當於

器材摘要

num Vapocoolant is the device name listed in this FDA 510(k) record. The listed applicant is 623 Medical, LLC. It received FDA 510(k) clearance on 2020-12-21 under 510(k) number K202782. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常見問題

What is the num Vapocoolant?

num Vapocoolant is a medical device that received FDA 510(k) clearance on 2020-12-21. The listed applicant is 623 Medical, LLC. The 510(k) number is K202782.

When did num Vapocoolant receive FDA 510(k) clearance?

num Vapocoolant received FDA 510(k) clearance on 2020-12-21, under 510(k) number K202782.

Who is the listed applicant for num Vapocoolant?

The FDA 510(k) record lists 623 Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for num Vapocoolant?

The FDA product code for num Vapocoolant is MLY.

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：MLY）

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。

K261684冷凍噴霧機 TACryosurgery, Inc.K260870Gebauer's 疼痛輕鬆局部麻醉皮膚冷凍劑（霧狀噴劑和中等噴劑）Gebauer CompanyK243654牙科注射器Vapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLCK203661CRYO 北極，CRYO 企鵝Cryoscience North America, Inc.K201248針筒固定配件Vapocoolshot, Inc.

官方來源

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