Hokanson

FDA UDI

Class II (US FDA UDI)

by D. E. Hokanson, Inc.

Identity

Trade Name: Hokanson FDA UDI
Generic Name: Noninvasive vascular ultrasound system FDA UDI
Device Name: DOPPLER w/DETACHABLE TRANSDUCER; RoHS version - Portable, continuous wave Doppler for peripheral vascular use, with a detachable transducer. The instrument is battery operated and produces an audio signal proportional to the velocity of blood flow. The Doppler signal can be heard on the built-in loudspeaker or with stereo headphones which provide a sense of flow direction. The Doppler can also be used with a chart recorder for recording velocity waveforms. FDA UDI
Model / Reference: MD6 detachable FDA UDI
Description: DOPPLER w/DETACHABLE TRANSDUCER; RoHS version - Portable, continuous wave Doppler for peripheral vascular use, with a detachable transducer. The instrument is battery operated and produces an audio signal proportional to the velocity of blood flow. The Doppler signal can be heard on the built-in loudspeaker or with stereo headphones which provide a sense of flow direction. The Doppler can also be used with a chart recorder for recording velocity waveforms. FDA UDI

Identifiers

Catalog Number: 00781 FDA UDI
Primary DI / UDI-DI: 00817065021303 FDA UDI
510(k) Number: K901592 FDA UDI
FDA Product Code: DXK FDA UDI
GMDN Term: Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Noninvasive vascular ultrasound system

Hokanson by D. E. Hokanson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound system.

Summit Doppler — CooperSurgical, Inc. · Class II
Summit Doppler — CooperSurgical, Inc. · Class II
DigiDop — Newman Medical · Class II
NovaGuide™ Intelligent Ultrasound System — Novasignal Corporation · Class II
Vave — VAVE HEALTH INC · Class II
TRIA II Display Doppler — CooperSurgical, Inc. · Class II
Summit Doppler — CooperSurgical, Inc. · Class II
DigiDop — Newman Medical · Class II

Cleared under the same submission

K901592 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: D. E. Hokanson, Inc.

Sources (1)

FDA UDI 7fe84630-7def-4a87-90d1-6dbda8c8efdc 36 fields · synced Jun 8, 2026