FDA 510(k)

KerraCel Ag 凝胶纤维银离子敷料

K号: K162508 · 2017-02-13

决定日期2017-02-13

产品代码FRO

决定实质等同

器械摘要

KerraCel Ag Gelling Fiber Silver Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Exciton Technologies, Inc.. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K162508. 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 KerraCel Ag Gelling Fiber Silver Dressing?

KerraCel Ag Gelling Fiber Silver Dressing is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Exciton Technologies, Inc.. The 510(k) number is K162508.

When did KerraCel Ag Gelling Fiber Silver Dressing receive FDA 510(k) clearance?

KerraCel Ag Gelling Fiber Silver Dressing received FDA 510(k) clearance on 2017-02-13, under 510(k) number K162508.

Who is the listed applicant for KerraCel Ag Gelling Fiber Silver Dressing?

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

What is the FDA product code for KerraCel Ag Gelling Fiber Silver Dressing?

The FDA product code for KerraCel Ag Gelling Fiber Silver Dressing is FRO. This falls under the Anesthesiology category.

列明Exciton Technologies, 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。

K182680KerraContact Ag Perf 高级穿孔银离子伤口敷料

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