TERA HARZ
K号: K202846 · 2021-07-15
广告
申请人Graphy, Inc.
决定日期2021-07-15
产品代码EBF
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
TERA HARZ is the device name listed in this FDA 510(k) record. The listed applicant is Graphy, Inc.. It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K202846. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TERA HARZ?
TERA HARZ is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Graphy, Inc.. The 510(k) number is K202846.
When did TERA HARZ receive FDA 510(k) clearance?
TERA HARZ received FDA 510(k) clearance on 2021-07-15, under 510(k) number K202846.
Who is the listed applicant for TERA HARZ?
The FDA 510(k) record lists Graphy, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TERA HARZ?
The FDA product code for TERA HARZ is EBF.
列明Graphy, 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。
K253681TERA HARZ 硬牙托 (THD-C-500); TERA HARZ 硬牙托 (THD-C-1000); TERA HARZ 硬牙托 (THD-LP-500); TERA HARZ 硬牙托 (THD-LP-1000); TERA HARZ 硬牙托 (THD-P-500); TERA HARZ 硬牙托 (THD-P-1000); TERA HARZ 硬牙托 (THD-CP-500); TERA HARZ 硬牙托 (THD-CP-1000)K240597TERA HARZ CLEARK233502TERA HARZ IIK223355Tera Harz ClearK222414TERA HARZ 牙托
相关器械（代码：EBF）
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。
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。
广告