FDA 510(k)

Anexa Wound Flush, 無菌水 & 無菌生理鹽水

K 號：K161658 · 2016-09-14

決定日期2016-09-14

產品代碼FRO

決定相當於

器材摘要

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is the device name listed in this FDA 510(k) record. The listed applicant is Anexa Biomedical, Inc.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K161658. 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 Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Anexa Biomedical, Inc.. The 510(k) number is K161658.

When did Anexa Wound Flush, Sterile Water & Sterile Normal Saline receive FDA 510(k) clearance?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline received FDA 510(k) clearance on 2016-09-14, under 510(k) number K161658.

Who is the listed applicant for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

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

What is the FDA product code for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

The FDA product code for Anexa Wound Flush, Sterile Water & Sterile Normal Saline is FRO. This falls under the Anesthesiology category.

其他以 Anexa Biomedical, Inc. 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。

K172486Anexa Wound Flush, USP 適用水，以及 USP 適用正常鹽水（0.9% 氯化鈉）120 mL 杯，USP 適用水，以及 USP 適用正常鹽水（0.9% 氯化鈉）100mL 瓶，USP 適用水，以及 USP 適用正常鹽水（0.9% 氯化鈉）250mL 瓶，USP 適用水，以及 USP 適用正常鹽水（0.9% 氯化鈉）500mL 瓶

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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