FDA 510(k)

TACVAC

K号: K153459 · 2016-01-28

决定日期2016-01-28

产品代码BTA

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决定实质等同

器械摘要

TACVAC is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K153459. 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 TACVAC?

TACVAC is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Athena Gtx. The 510(k) number is K153459.

When did TACVAC receive FDA 510(k) clearance?

TACVAC received FDA 510(k) clearance on 2016-01-28, under 510(k) number K153459.

Who is the listed applicant for TACVAC?

The FDA 510(k) record lists Athena Gtx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TACVAC?

The FDA product code for TACVAC is BTA.

列明Athena Gtx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。

K191989WVSM（无线生命体征监测器）RWC + miniCap K173203Athena GTX 设备管理系统（ADMS）软件 K160582WiCap

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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