FDA 510(k)

TorrentX 識別器傷口清潔液

K 號：K203446 · 2021-09-23

決定日期2021-09-23

產品代碼FRO

決定相當於

器材摘要

TorrentX Wound Wash is the device name listed in this FDA 510(k) record. The listed applicant is Next Science, LLC. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K203446. 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 TorrentX Wound Wash?

TorrentX Wound Wash is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Next Science, LLC. The 510(k) number is K203446.

When did TorrentX Wound Wash receive FDA 510(k) clearance?

TorrentX Wound Wash received FDA 510(k) clearance on 2021-09-23, under 510(k) number K203446.

Who is the listed applicant for TorrentX Wound Wash?

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

What is the FDA product code for TorrentX Wound Wash?

The FDA product code for TorrentX Wound Wash is FRO. This falls under the Anesthesiology category.

其他以 Next Science, LLC 為申請人之記錄

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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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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