External Pacemaker Analyzer

Primary DI
B3359600
Brand
External Pacemaker Analyzer
Company
NETECH CORPORATION
Model
EXPMT 2000
Catalog number
960
Device description
The EXPMT 2000 pacemaker analyzer is an advanced microprocessor based test instrument designed to accurately measure the output parameters of all external pacemakers, including both transthoracic and transcutaneous devices. The instrument is easy to use via the menu structure presented on a large four line LCD display. Resulting measurements of the tests performed are simultaneously shown on the LCD display. The EXPMT 2000 is compact, lightweight, and rugged. It may be operated with one 9 volt battery or with an optional AC adapter. A standard RS232 serial port allows for printing and storage of results with optional printers and PDAs.
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DTCAnalyzer, Pacemaker Generator Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTCAnalyzer, Pacemaker Generator FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961582000EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.1996-11-08DTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3359600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker analyserAn electronic instrument designed to test an external pacemaker to ensure compliance with performance specifications. The device connects to the output of the pacemaker to test any or all of the pulse generator's parameters including pulse duration, pulse amplitude, pulse rate, and sensing threshold. The device may be used to test the function of an external pacemaker periodically, after repair, or for training purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177242153
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B33596020000External Pacemaker AnalyzerAdvance EXPMT 2000960-20002024-08-23
B3356600Defibrillator / Transcutaneous Pacemaker AnalyzerDELTA 33006602020-03-05
B3356500Defibrillator AnalyzerDelta 30006502017-06-16
B3359500External Pacemaker AnanlyzerEXPMT 20009502017-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33596020000External Pacemaker AnalyzerNETECH CORPORATIONDTC2024-08-23
00763000688400CareLink SmartSync™MEDTRONIC, INC.DTC2022-10-28
04035479092443PK-141/2.8mBIOTRONIK SE & Co. KGDTC2021-05-06
00763000201289CareLink SmartSync™MEDTRONIC, INC.DTC2019-06-01
00763000002039CareLink SmartSync™ Azure Astra ApplicationMEDTRONIC, INC.DTC2019-04-06
00643169957657CareLink SmartSync™MEDTRONIC, INC.DTC2019-03-30
00850540007157SigmaPace 1000FLUKE ELECTRONICS CORPORATIONDTC2018-05-24
00802526580208NABOSTON SCIENTIFIC CORPORATIONDTC2017-11-16
B3359500External Pacemaker AnanlyzerNETECH CORPORATIONDTC2017-06-16
00643169833715CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169833739CareLink SmartSync™ Common ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169833753CareLink SmartSync™ PSA ApplicationMEDTRONIC, INC.DTC2017-05-25
00643169868540CareLink SmartSync™MEDTRONIC, INC.DTC2017-05-25