FDA 510(k)

Anexa 溃疡冲洗液，无菌水 & 无菌生理盐水

K号: K161658 · 2016-09-14

决定日期2016-09-14

产品代码FRO

决定实质等同

器械摘要

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.

常见问题

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.

列明Anexa Biomedical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K172486Anexa 溃疡冲洗液，USP 无菌水，和 USP 无菌生理盐水（0.9% 氯化钠）120 mL 杯，USP 无菌水，和 USP 无菌生理盐水（0.9% 氯化钠）100mL 瓶，USP 无菌水，和 USP 无菌生理盐水（0.9% 氯化钠）250mL 瓶，USP 无菌水，和 USP 无菌生理盐水（0.9% 氯化钠）500mL 瓶

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