FDA.reportPublic FDA data

Hokanson

Primary DI
00817065021327
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
MD6
Catalog number
00863
Device 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.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXKEchocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXKEchocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901592000MODEL MD-5 DOPPLERD. E. Hokanson, Inc.1990-10-22DXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817065021327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065021327008170650213278170650213270817065021327

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, battery-poweredA hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-999-8251info@deh-inc.com
425-882-1689info@deh-inc.com

Regulatory Flags#

DUNS number
071829634
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817065020153Hokanson03845038452026-03-27
00817065022614Hokanson03844038442026-03-27
00817065022621Hokanson03843038432026-03-27
00817065022638Hokanson03842038422026-03-27
00817065022645Hokanson03841038412026-03-27
00817065022652Hokanson03840038402026-03-27
00817065020849Hokanson03759037592016-09-09
00817065022348HokansonDP2.5™431012017-07-18
00817065022607Hokanson03027030272021-10-14
00817065022584Hokanson43305433052021-09-16
00817065022591Hokanson43306433062021-09-16
00817065022522Hokanson43660436602020-04-27
00817065022539Hokanson43662436622020-04-27
00817065022546Hokanson43664436642020-04-27
00817065022553Hokanson43666436662020-04-27
00817065022560Hokanson43668436682020-04-27
00817065022508HokansonDP2.0™037382019-06-14
00817065020061Hokanson03602036022016-09-09
00817065020085Hokanson03079030792016-09-09
00817065020139Hokanson03686036862016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729982500Ultra ICE™ Plus - PIBOSTON SCIENTIFIC CORPORATIONDXK2021-02-02
00817065021303HokansonD.E.HOKANSON, INC.DXK2016-09-16
00817065021334HokansonD.E.HOKANSON, INC.DXK2016-09-16
00817065021358HokansonD.E.HOKANSON, INC.DXK2016-09-16
00817065021365HokansonD.E.HOKANSON, INC.DXK2016-09-16
00817065021372HokansonD.E.HOKANSON, INC.DXK2016-09-16
00817065021426HokansonD.E.HOKANSON, INC.DXK2016-09-16
00817065021464HokansonD.E.HOKANSON, INC.DXK2016-09-16
00817065021310HokansonD.E.HOKANSON, INC.DXK2016-08-31