FDA.reportPublic FDA data

Hokanson

Primary DI
00817065021464
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
MD6 Doppler probe
Catalog number
01952
Device description
DOPPLER PROBE - A complete detachable Doppler probe replacement set.
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
00817065021464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065021464008170650214648170650214640817065021464

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device.

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
00817065021327HokansonD.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
00817065021310HokansonD.E.HOKANSON, INC.DXK2016-08-31