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; RoHS version - Portable, continuous wave Doppler for peripheral vascular use. 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 FDA UDI
Description: DOPPLER; RoHS version - Portable, continuous wave Doppler for peripheral vascular use. 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: 00863 FDA UDI
Primary DI / UDI-DI: 00817065021327 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: D. E. Hokanson, Inc.

Sources (1)

FDA UDI 5b18f525-8c69-4535-85df-ccbe7f900d9d 36 fields · synced Jun 8, 2026