FDA.reportPublic FDA data

Hokanson

Primary DI
00817065021433
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
PPG sensor
Catalog number
01543
Device description
PHOTOTRANSDUCER; 4 PIN CONNECTOR - A plethysmograph sensor that attaches to an electronic plethysmograph instrument, used to measure volume changes due to blood flow changes in a limb or digit. The plethysmograph instrument measures the signal to determine changes in blood volume in the tissue under the sensor.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSBPlethysmograph, Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K896034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896034000PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEMD. E. Hokanson, Inc.1990-01-18DSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817065021433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065021433008170650214338170650214330817065021433

GMDN Terms#

Term, Definition table
TermDefinition
Limb plethysmograph phototransducerA photoelectric device designed to be applied externally to a portion of a limb (e.g., a fingertip, toe) for the transcutaneous measurement of blood volume using light detection during limb plethysmography. It is intended to be connected to a limb plethysmograph (not included), whereby volume changes are represented graphically to represent blood flow/pulse. It is designed for use during vascular function assessment in a limb (e.g., measurement of toe brachial pressure index). Although similar to a pulse oximeter probe, it is dedicated to limb plethysmography, and not capable of oxygen saturation measurements. 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

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