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FDA 510(k)

XERO-alpha

K-Number: K242591 · 2024-11-01

Decision Date2024-11-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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?

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

What is the FDA product code for XERO-alpha?

The FDA product code for XERO-alpha is EHD.

Other records listing DRTECH Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 22 devices →

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.