FDA 510(k)

EndoRotor 控制台, EndoRotor 导管, EndoRotor 样本陷阱, EndoRotor 过滤器套装, EndoRotor 滚筒支架

K号: K190715 · 2019-12-13

决定日期2019-12-13

产品代码ERL

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is the device name listed in this FDA 510(k) record. The listed applicant is Interscope, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K190715. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Interscope, Inc.. The 510(k) number is K190715.

When did EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand receive FDA 510(k) clearance?

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand received FDA 510(k) clearance on 2019-12-13, under 510(k) number K190715.

Who is the listed applicant for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

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

What is the FDA product code for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand?

The FDA product code for EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand is ERL.

列明Interscope, 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。

K181127EndoRotor 控制台, EndoRotor 导管, EndoRotor 样本陷阱, EndoRotor 过滤器套装, EndoRotor 脚踏控制器 K170120EndoRotor

官方来源

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