FDA 510(k)

BASE290 LED 照明灯

K号: K233518 · 2023-11-02

决定日期2023-11-02

产品代码EBZ

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决定实质等同

器械摘要

BASE290 LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Handpiece Headquarters. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K233518. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BASE290 LED Curing Light?

BASE290 LED Curing Light is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Handpiece Headquarters. The 510(k) number is K233518.

When did BASE290 LED Curing Light receive FDA 510(k) clearance?

BASE290 LED Curing Light received FDA 510(k) clearance on 2023-11-02, under 510(k) number K233518.

Who is the listed applicant for BASE290 LED Curing Light?

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

What is the FDA product code for BASE290 LED Curing Light?

The FDA product code for BASE290 LED Curing Light is EBZ.

列明Handpiece Headquarters为申报人的其他记录

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