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FDA 510(k)

BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T

K-Number: K010452 · 2002-02-12

ApplicantKoven Technology, Inc.
Decision Date2002-02-12
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T 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 2002-02-12 under 510(k) number K010452. 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 BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T?

BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T is a medical device that received FDA 510(k) clearance on 2002-02-12. The listed applicant is Koven Technology, Inc.. The 510(k) number is K010452.

When did BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T receive FDA 510(k) clearance?

BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T received FDA 510(k) clearance on 2002-02-12, under 510(k) number K010452.

Who is the listed applicant for BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T?

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 BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T?

The FDA product code for BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T is DPW.

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Related Devices (Code: DPW)

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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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