FDA.reportPublic FDA data

External Pacemaker Ananlyzer

Primary DI
B3359500
Brand
External Pacemaker Ananlyzer
Company
NETECH CORPORATION
Model
EXPMT 2000
Catalog number
950
Device description
The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, transcutaneous and Atrial and Ventricular sequential pacemakers.Operation of the analyzer is menu driven via eight tactile keys and a large four line LCD display. Test measurements are simultaneously presented on the display. Five ECG snaps are standard along with an RS-232 serial port that allows for printing both a heading and test measurements on a separate printer. Information may also be sent to an external device. The external test load has twelve user-selectable loads from 100 to 1000 Ohms for use with transcutaneous pacemakers.
Published
2017-06-16
Public version status
Update
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
B3359500PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177242153
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B33596020000External Pacemaker AnalyzerAdvance EXPMT 2000960-20002024-08-23
B3359600External Pacemaker AnalyzerEXPMT 20009602023-07-03
B3356600Defibrillator / Transcutaneous Pacemaker AnalyzerDELTA 33006602020-03-05
B3356500Defibrillator AnalyzerDelta 30006502017-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33596020000External Pacemaker AnalyzerNETECH CORPORATIONDTC2024-08-23
B3359600External Pacemaker AnalyzerNETECH CORPORATIONDTC2023-07-03
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
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