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FDA 510(k)

GyroStim

K 號：K220231 · 2022-04-27

申請人Ultrathera Technologies, Inc.
決定日期2022-04-27
產品代碼LXV
決定相當於

器材摘要

GyroStim is the device name listed in this FDA 510(k) record. The listed applicant is Ultrathera Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220231. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

常見問題

What is the GyroStim?

GyroStim is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Ultrathera Technologies, Inc.. The 510(k) number is K220231.

When did GyroStim receive FDA 510(k) clearance?

GyroStim received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220231.

Who is the listed applicant for GyroStim?

The FDA 510(k) record lists Ultrathera Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GyroStim?

The FDA product code for GyroStim is LXV.

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：LXV）

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。

K200529歐里安Interacoustics A/SK192652TRVInteracoustics A/SK183661ClearEdge 平衡系統Quadrant BiosciencesK190735EQ 平衡Upright Science, Inc.K173669K-D 平衡King-Devick Technologies, Inc.

官方來源

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