EXTRON 5; EXTRON 7
K-Number: K230871 · 2023-08-17
ApplicantDRTECH Corporation
Decision Date2023-08-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EXTRON 5; EXTRON 7 is a medical device manufactured by DRTECH Corporation. It received FDA 510(k) clearance on 2023-08-17 under approval number K230871. 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 5; EXTRON 7?
EXTRON 5; EXTRON 7 is a medical device that received FDA 510(k) clearance on 2023-08-17. It is manufactured by DRTECH Corporation. The 510(k) number is K230871.
When was EXTRON 5; EXTRON 7 approved by the FDA?
EXTRON 5; EXTRON 7 received FDA 510(k) clearance on 2023-08-17, under approval number K230871.
What company makes EXTRON 5; EXTRON 7?
EXTRON 5; EXTRON 7 is manufactured by DRTECH Corporation.
What is the FDA product code for EXTRON 5; EXTRON 7?
The FDA product code for 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.