FDA 510(k)

XERO-alpha

K号: K242591 · 2024-11-01

决定日期2024-11-01

产品代码EHD

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决定实质等同

器械摘要

XERO-alpha is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K242591. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XERO-alpha?

XERO-alpha is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is DRTECH Corporation. The 510(k) number is K242591.

When did XERO-alpha receive FDA 510(k) clearance?

XERO-alpha received FDA 510(k) clearance on 2024-11-01, under 510(k) number K242591.

Who is the listed applicant for XERO-alpha?

FDA 510(k)记录列出了DRTECH Corporation为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for XERO-alpha?

The FDA product code for XERO-alpha is EHD.

列明DRTECH Corporation为申报人的其他记录

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