免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Aqua Care & Accu-Rinse, 无菌水 & 无菌生理盐水

K号: K170270 · 2017-06-23

申请人Ls Scientific Inc. D.B.A. Kse Scientific
决定日期2017-06-23
产品代码FRO
决定实质等同

器械摘要

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is the device name listed in this FDA 510(k) record. The listed applicant is Ls Scientific Inc. D.B.A. Kse Scientific. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K170270. 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 Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Ls Scientific Inc. D.B.A. Kse Scientific. The 510(k) number is K170270.

When did Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline receive FDA 510(k) clearance?

Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline received FDA 510(k) clearance on 2017-06-23, under 510(k) number K170270.

Who is the listed applicant for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

The FDA 510(k) record lists Ls Scientific Inc. D.B.A. Kse Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline?

The FDA product code for Aqua Care & Accu-Rinse, Sterile Water & Sterile Normal Saline is FRO. This falls under the Anesthesiology category.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K254168Actolind®（06.3637. Actolind®凝胶加强型）ACTO GmbHK254041SkinSmart 抗菌保湿凝胶Magic Science Supply, LLCK261646Redermax® 抗菌伤口基质Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 抗菌伤口凝胶Silverceuticals, Inc.K261023Microdacyn 伤口冲洗溶液Sonoma Pharmaceuticals, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑