FDA 510(k)

Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元

K号: K222643 · 2022-10-19

决定日期2022-10-19

产品代码PBY

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决定实质等同

器械摘要

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is the device name listed in this FDA 510(k) record. The listed applicant is Sirius Medical Systems B.V.. It received FDA 510(k) clearance on 2022-10-19 under 510(k) number K222643. The device is classified under product code PBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is a medical device that received FDA 510(k) clearance on 2022-10-19. The listed applicant is Sirius Medical Systems B.V.. The 510(k) number is K222643.

When did Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit receive FDA 510(k) clearance?

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit received FDA 510(k) clearance on 2022-10-19, under 510(k) number K222643.

Who is the listed applicant for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

The FDA 510(k) record lists Sirius Medical Systems B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit?

The FDA product code for Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit is PBY.

列明Sirius Medical Systems B.V.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。

K223682Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元 K200734Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元

相关器械（代码：PBY）

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。

K223682Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K200734Sirius Pintuition Seed, Sirius Pintuition 探头, Sirius Pintuition 基础单元Sirius Medical Systems B.V.K163667RFID定位系统-定位器读取器，RFID定位系统-定位器手术探头，RFID定位系统-定位器手术探头（5件装），RFID定位系统-标签应用器，RFID定位系统 -标签应用器（10件装）Health Beacons, Inc.K163541Magseed磁标记系统Endomagnetics Ltd.,K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd.,

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