FDA 510(k)

Entellus 医疗加固麻醉针

K号: K163435 · 2017-04-05

决定日期2017-04-05

产品代码BSP

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Entellus Medical Reinforced Anesthesia Needle is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K163435. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Entellus Medical Reinforced Anesthesia Needle?

Entellus Medical Reinforced Anesthesia Needle is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K163435.

When did Entellus Medical Reinforced Anesthesia Needle receive FDA 510(k) clearance?

Entellus Medical Reinforced Anesthesia Needle received FDA 510(k) clearance on 2017-04-05, under 510(k) number K163435.

Who is the listed applicant for Entellus Medical Reinforced Anesthesia Needle?

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

What is the FDA product code for Entellus Medical Reinforced Anesthesia Needle?

The FDA product code for Entellus Medical Reinforced Anesthesia Needle is BSP.

列明Entellus Medical, 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。

K220027Audion ET 扩张系统 K163509XprESS耳鼻喉扩张系统

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。