FDA 510(k)

BTL-99-OC

K号: K230657 · 2024-02-01

决定日期2024-02-01

产品代码QCI

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

BTL-99-OC is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2024-02-01 under 510(k) number K230657. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BTL-99-OC?

BTL-99-OC is a medical device that received FDA 510(k) clearance on 2024-02-01. The listed applicant is BTL Industries, Inc.. The 510(k) number is K230657.

When did BTL-99-OC receive FDA 510(k) clearance?

BTL-99-OC received FDA 510(k) clearance on 2024-02-01, under 510(k) number K230657.

Who is the listed applicant for BTL-99-OC?

FDA 510(k)记录中列出了BTL Industries, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for BTL-99-OC?

The FDA product code for BTL-99-OC is QCI.