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FDA 510(k)

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX

K-Number: K031504 · 2003-07-18

ApplicantKoven Technology, Inc.
Decision Date2003-07-18
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX is the device name listed in this FDA 510(k) record. The listed applicant is Koven Technology, Inc.. It received FDA 510(k) clearance on 2003-07-18 under 510(k) number K031504. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX?

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX is a medical device that received FDA 510(k) clearance on 2003-07-18. The listed applicant is Koven Technology, Inc.. The 510(k) number is K031504.

When did ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX receive FDA 510(k) clearance?

ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX received FDA 510(k) clearance on 2003-07-18, under 510(k) number K031504.

Who is the listed applicant for ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX?

The FDA 510(k) record lists Koven Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX?

The FDA product code for ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX is KNG.

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Other records listing Koven Technology, Inc. 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.

K201114Bidop 7K153762Smartdop XT6K080178VALVULOTOME BY KOVENK050601SMARTDOP 45 VASCULAR DOPPLERK031931ECHO SOUNDER EX-101EX 8 MHZK023143ECHO SOUNDER, ES-102EX

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Related Devices (Code: KNG)

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

View on FDA Database →

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

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