XERO-alpha
K-Number: K242591 · 2024-11-01
ApplicantDRTECH Corporation
Decision Date2024-11-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
XERO-alpha is a medical device manufactured by DRTECH Corporation. It received FDA 510(k) clearance on 2024-11-01 under approval 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. It is manufactured by DRTECH Corporation. The 510(k) number is K242591.
When was XERO-alpha approved by the FDA?
XERO-alpha received FDA 510(k) clearance on 2024-11-01, under approval number K242591.
What company makes XERO-alpha?
XERO-alpha is manufactured by DRTECH Corporation.
What is the FDA product code for XERO-alpha?
The FDA product code for XERO-alpha is EHD.
Other Devices by DRTECH Corporation
Related Devices (Code: EHD)
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.