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Mini Doppler II Ultrasound Blood Flow Detector

by Koven and Assoc., Inc.

510(k) K915550

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK915550 Date10 Dec 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mini Doppler II Ultrasound Blood Flow Detector is a flowmeter, blood, cardiovascular device used to detect blood flow. It is an ultrasound device that utilizes Doppler technology to measure blood flow.

The device is supplied as a single unit and is intended for use in a clinical setting. It is classified as a class 2 device and has been cleared by the FDA with a 510(k) number of K915550. The device is used in cardiovascular procedures and is regulated under regulation number 870.2100.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mini Doppler II used for?

    The Mini Doppler II is used to detect blood flow in cardiovascular procedures, utilizing Doppler technology to measure blood flow in a clinical setting.

  • Is the Mini Doppler II a single-use device?

    The device is supplied as a single unit, but its intended use as single-use or reusable is not specified, so it should be used according to the manufacturer's instructions.

  • What regulatory classification does the Mini Doppler II have?

    The Mini Doppler II is classified as a class 2 device and has been cleared by the FDA with a 510(k) number of K915550, regulated under regulation number 870.2100.