FDA 510(k)

肩部起搏器

K号: K210674 · 2021-08-24

决定日期2021-08-24

产品代码IPF

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决定实质等同

器械摘要

Shoulder Pacemaker is the device name listed in this FDA 510(k) record. The listed applicant is Ncs Lab Srl. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K210674. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Shoulder Pacemaker?

Shoulder Pacemaker is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Ncs Lab Srl. The 510(k) number is K210674.

When did Shoulder Pacemaker receive FDA 510(k) clearance?

Shoulder Pacemaker received FDA 510(k) clearance on 2021-08-24, under 510(k) number K210674.

Who is the listed applicant for Shoulder Pacemaker?

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

What is the FDA product code for Shoulder Pacemaker?

The FDA product code for Shoulder Pacemaker is IPF.

列明Ncs Lab Srl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。

K220994Shoulder PacemakerTM K160500Elite SPK，Compasso，Elite SPK 套件

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。