FDA 510(k)

EXTRON 5; EXTRON 7

K-Number: K230871 · 2023-08-17

Decision Date2023-08-17

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EXTRON 5; EXTRON 7 is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2023-08-17 under 510(k) 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. The listed applicant is DRTECH Corporation. The 510(k) number is K230871.

When did EXTRON 5; EXTRON 7 receive FDA 510(k) clearance?

EXTRON 5; EXTRON 7 received FDA 510(k) clearance on 2023-08-17, under 510(k) number K230871.

Who is the listed applicant for EXTRON 5; EXTRON 7?

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 EXTRON 5; EXTRON 7?

The FDA product code for EXTRON 5; EXTRON 7 is OWB.

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.

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Official Source

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