生理盐水伤口冲洗剂，SteriCleanse™
K号: K183662 · 2019-09-12
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器械摘要
Saline Wound Wash, SteriCleanse(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Consumer Products, Inc.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K183662. 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 Saline Wound Wash, SteriCleanse(TM)?
Saline Wound Wash, SteriCleanse(TM) is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Ascent Consumer Products, Inc.. The 510(k) number is K183662.
When did Saline Wound Wash, SteriCleanse(TM) receive FDA 510(k) clearance?
Saline Wound Wash, SteriCleanse(TM) received FDA 510(k) clearance on 2019-09-12, under 510(k) number K183662.
Who is the listed applicant for Saline Wound Wash, SteriCleanse(TM)?
The FDA 510(k) record lists Ascent Consumer Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Saline Wound Wash, SteriCleanse(TM)?
The FDA product code for Saline Wound Wash, SteriCleanse(TM) is FRO. This falls under the Anesthesiology category.
相关临床试验
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相关器械（代码：FRO）
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。
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官方来源
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