FDA.reportPublic FDA data

Hokanson

Primary DI
00817065021396
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
RT2000
Catalog number
00334
Device description
ECG TRIGGER - A battery powered instrument used to acquire an ECG signal from a subject. The instrument filters and amplifies the patient's ECG R-wave, then sends the signal to a parent device via and optically isolated interface cable. The output signal can be used by the parent device to synchronize another event with the subject’s R-Wave. The waveform is NOT used for analysis or diagnosis due to the ECG signal filtering.
Published
2016-09-22
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
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023707000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023707000A16 BLOOD FLOW MEASUREMENT SYSTEMD. E. Hokanson, Inc.2003-02-12JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817065021396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065021396008170650213968170650213960817065021396

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic modulated activatorA hand-held, battery-powered device intended to gather electrocardiographic (ECG) data for real-time control (activation) of a separate device (e.g., a regulator during rapid vascular cuff inflation) at a specific point during the patient’s cardiac cycle. It a small electronic unit with ECG leads intended to be used as part of noninvasive patient diagnosis; it is not designed to gather ECG data for analysis/diagnosis.

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
00862467000333PADnet XpressCollaborative Care Diagnostics, LLCJOM2026-02-04
08690020003017VitalScan ANSMedeia, Inc.JOM2025-02-05
08690020003031VitalScan HRVMedeia, Inc.JOM2025-02-05
B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCJOM2024-03-05
B322H0011LD-EKGLD TECHNOLOGY, LLCJOM2024-03-05
05051968035370DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2022-10-10
03830059851523MESI mTABLET TBIMESI d.o.o.JOM2022-04-25
03830059850366MESI ABPI MDMESI d.o.o.JOM2021-07-09
03830059851141MESI mTABLET ABIMESI d.o.o.JOM2021-07-09
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00191237000014SA-3000PMedicore Co., Ltd.JOM2019-04-10
10191237000011SA-3000PMedicore Co., Ltd.JOM2019-04-10
00191237000038Max PulseMedicore Co., Ltd.JOM2019-03-05
40191237000036Max PulseMedicore Co., Ltd.JOM2019-03-05
B322C0011TBL-ABILD TECHNOLOGY, LLCJOM2019-01-16
04051526846302MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526846463MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526849631MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526903616MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257188439MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257189085MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00817065022454HokansonD.E.HOKANSON, INC.JOM2017-12-12
05051968030429DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
05051968030436DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
00860446000312APG Air-PlethysmographACI MEDICAL LLCJOM2016-09-24
00862467000302PADnetCollaborative Care Diagnostics, LLCJOM2016-09-24