EXTRON 3; EXTRON 5; EXTRON 7
K-Number: K250010 · 2025-06-10
ApplicantDRTECH Corporation
Decision Date2025-06-10
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EXTRON 3; EXTRON 5; EXTRON 7 is a medical device manufactured by DRTECH Corporation. It received FDA 510(k) clearance on 2025-06-10 under approval number K250010. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EXTRON 3; EXTRON 5; EXTRON 7?
EXTRON 3; EXTRON 5; EXTRON 7 is a medical device that received FDA 510(k) clearance on 2025-06-10. It is manufactured by DRTECH Corporation. The 510(k) number is K250010.
When was EXTRON 3; EXTRON 5; EXTRON 7 approved by the FDA?
EXTRON 3; EXTRON 5; EXTRON 7 received FDA 510(k) clearance on 2025-06-10, under approval number K250010.
What company makes EXTRON 3; EXTRON 5; EXTRON 7?
EXTRON 3; EXTRON 5; EXTRON 7 is manufactured by DRTECH Corporation.
What is the FDA product code for EXTRON 3; EXTRON 5; EXTRON 7?
The FDA product code for EXTRON 3; EXTRON 5; EXTRON 7 is OWB.
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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.