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FDA 510(k)

Aqua Care & Accu-Rinse, 無菌水 & 無菌生理鹽水

K 號：K170270 · 2017-06-23

申請人Ls Scientific Inc. D.B.A. Kse Scientific
決定日期2017-06-23
產品代碼FRO
決定相當於

器材摘要

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is the device name listed in this FDA 510(k) record. The listed applicant is Ls Scientific Inc. D.B.A. Kse Scientific. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K170270. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Ls Scientific Inc. D.B.A. Kse Scientific. The 510(k) number is K170270.

When did Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline receive FDA 510(k) clearance?

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline received FDA 510(k) clearance on 2017-06-23, under 510(k) number K170270.

Who is the listed applicant for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

The FDA 510(k) record lists Ls Scientific Inc. D.B.A. Kse Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

The FDA product code for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is FRO. This falls under the Anesthesiology category.

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：FRO）

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。

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官方來源

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