FDA 510(k)

Vitreq一次性激光探头、光纤和烛台

K号: K182646 · 2019-05-01

决定日期2019-05-01

产品代码HQB

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决定实质等同

器械摘要

Vitreq disposable laser probes, light fibers and Chandelier is the device name listed in this FDA 510(k) record. The listed applicant is VitreQ BV. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K182646. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vitreq disposable laser probes, light fibers and Chandelier?

Vitreq disposable laser probes, light fibers and Chandelier is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is VitreQ BV. The 510(k) number is K182646.

When did Vitreq disposable laser probes, light fibers and Chandelier receive FDA 510(k) clearance?

Vitreq disposable laser probes, light fibers and Chandelier received FDA 510(k) clearance on 2019-05-01, under 510(k) number K182646.

Who is the listed applicant for Vitreq disposable laser probes, light fibers and Chandelier?

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

What is the FDA product code for Vitreq disposable laser probes, light fibers and Chandelier?

The FDA product code for Vitreq disposable laser probes, light fibers and Chandelier is HQB.

列明VitreQ BV为申报人的其他记录

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