FDA 510(k)

SKAN C PULSAR

K号: K251893 · 2025-12-16

决定日期2025-12-16

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

SKAN C PULSAR is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Limited. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K251893. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SKAN C PULSAR?

SKAN C PULSAR is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Skanray Technologies Limited. The 510(k) number is K251893.

When did SKAN C PULSAR receive FDA 510(k) clearance?

SKAN C PULSAR received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251893.

Who is the listed applicant for SKAN C PULSAR?

The FDA 510(k) record lists Skanray Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKAN C PULSAR?

The FDA product code for SKAN C PULSAR is OWB.

列明Skanray Technologies Limited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。

K231761PodSKAN HF诊断X射线系统 K220518SKANRAD 400 K212940Skanmobile, Skanmobile-Dr

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