FDA 510(k)

EXTRON 3; EXTRON 5; EXTRON 7

K号: K250010 · 2025-06-10

决定日期2025-06-10

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

EXTRON 3; 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 2025-06-10 under 510(k) number K250010. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is DRTECH Corporation. The 510(k) number is K250010.

When did EXTRON 3; EXTRON 5; EXTRON 7 receive FDA 510(k) clearance?

EXTRON 3; EXTRON 5; EXTRON 7 received FDA 510(k) clearance on 2025-06-10, under 510(k) number K250010.

Who is the listed applicant for EXTRON 3; EXTRON 5; EXTRON 7?

FDA 510(k)记录列出了DRTECH Corporation为申请人。这本身并不足以确立该设备制造商的身份。

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.

列明DRTECH Corporation为申报人的其他记录

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