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FDA 510(k)

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR

K-Number: K920333 · 1993-01-22

ApplicantKoven and Assoc., Inc.
Decision Date1993-01-22
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Koven and Assoc., Inc.. It received FDA 510(k) clearance on 1993-01-22 under 510(k) number K920333. 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 SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR?

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR is a medical device that received FDA 510(k) clearance on 1993-01-22. The listed applicant is Koven and Assoc., Inc.. The 510(k) number is K920333.

When did SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR receive FDA 510(k) clearance?

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR received FDA 510(k) clearance on 1993-01-22, under 510(k) number K920333.

Who is the listed applicant for SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR?

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

What is the FDA product code for SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR?

The FDA product code for SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR 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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