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FDA 510(k)

SOMAVAC 100 Sustained Vacuum System

K号: K222856 · 2022-10-19

申请人Somavac Medical Solutions, Inc.
决定日期2022-10-19
产品代码BTA
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

SOMAVAC 100 Sustained Vacuum System is the device name listed in this FDA 510(k) record. The listed applicant is Somavac Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-10-19 under 510(k) number K222856. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SOMAVAC 100 Sustained Vacuum System?

SOMAVAC 100 Sustained Vacuum System is a medical device that received FDA 510(k) clearance on 2022-10-19. The listed applicant is Somavac Medical Solutions, Inc.. The 510(k) number is K222856.

When did SOMAVAC 100 Sustained Vacuum System receive FDA 510(k) clearance?

SOMAVAC 100 Sustained Vacuum System received FDA 510(k) clearance on 2022-10-19, under 510(k) number K222856.

Who is the listed applicant for SOMAVAC 100 Sustained Vacuum System?

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

What is the FDA product code for SOMAVAC 100 Sustained Vacuum System?

The FDA product code for SOMAVAC 100 Sustained Vacuum System is BTA.

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

列明Somavac Medical Solutions, 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。

K231063SOMAVAC® 100 持续真空系统K180606SOMAVAC Device

相关器械（代码：BTA）

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。

K253629Momcozy 鼻吸器 (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby 鼻吸器（BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021）Shenzhen Root Innovation Technology Co., Ltd.K260892吸水泵（SU-90）Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473电动鼻吸器（BC027, BC030, BC033, BC035, BC035B）Shenzhen Kingboom Technology Co., Ltd.K253107电动鼻吸器 (DT10 和 DT50, DX80, DX85, DX86 和 DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147电动鼻吸器（BC026, BC025, BC023, BC028, BC029, BC036）Shenzhen Kingboom Technology Co., Ltd.

官方来源

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