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FDA 510(k)

MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR

K-Number: K915550 · 1992-12-10

ApplicantKoven and Assoc., Inc.
Decision Date1992-12-10
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINI DOPPLER II ULTRASOUND 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 1992-12-10 under 510(k) number K915550. 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 MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR?

MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR is a medical device that received FDA 510(k) clearance on 1992-12-10. The listed applicant is Koven and Assoc., Inc.. The 510(k) number is K915550.

When did MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR receive FDA 510(k) clearance?

MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR received FDA 510(k) clearance on 1992-12-10, under 510(k) number K915550.

Who is the listed applicant for MINI DOPPLER II ULTRASOUND 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 MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR?

The FDA product code for MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR is 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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