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FDA 510(k)

ECHO SOUNDER EX-101EX 8 MHZ

K-Number: K031931 · 2004-02-13

ApplicantKoven Technology, Inc.
Decision Date2004-02-13
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECHO SOUNDER EX-101EX 8 MHZ 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 2004-02-13 under 510(k) number K031931. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO SOUNDER EX-101EX 8 MHZ?

ECHO SOUNDER EX-101EX 8 MHZ is a medical device that received FDA 510(k) clearance on 2004-02-13. The listed applicant is Koven Technology, Inc.. The 510(k) number is K031931.

When did ECHO SOUNDER EX-101EX 8 MHZ receive FDA 510(k) clearance?

ECHO SOUNDER EX-101EX 8 MHZ received FDA 510(k) clearance on 2004-02-13, under 510(k) number K031931.

Who is the listed applicant for ECHO SOUNDER EX-101EX 8 MHZ?

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 EX-101EX 8 MHZ?

The FDA product code for ECHO SOUNDER EX-101EX 8 MHZ is DPW.

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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 DOPPLERK031504ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EXK023143ECHO SOUNDER, ES-102EX

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Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc.

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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