FDA.reportPublic FDA data

Defibrillator Analyzer

Primary DI
B3356500
Brand
Defibrillator Analyzer
Company
NETECH CORPORATION
Model
Delta 3000
Catalog number
650
Device description
Delta 3000 is a full function defibrillator analyzer including Transcutaneous Pacemakers. In addition to the capability of testing all bi-polar defibrillators, it tests all Transcutaneous pacers, Atrial and Ventricular pacemakers. Delta 3000 is compact, light weight and easy to use. Among the functions include energy, peak voltage as well as cardio version, 10 lead ECG Arrhythmia waveform.Test results can be easily uploaded to a PC through the serial port.
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
DRLTester, Defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRLTester, DefibrillatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961595000DEFIBRILLATOR ANALYZER, DELTA 1000Netech Corp.1996-10-29DRL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3356500PrimaryHIBCC0

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
B3359500External Pacemaker AnanlyzerEXPMT 20009502017-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3356600Defibrillator / Transcutaneous Pacemaker AnalyzerNETECH CORPORATIONDRL2020-03-05
00850540007119Impulse 6000DFLUKE ELECTRONICS CORPORATIONDRL2018-05-24
00850540007126Impulse 7000DPFLUKE ELECTRONICS CORPORATIONDRL2018-05-24
00850540007133Impulse 4000FLUKE ELECTRONICS CORPORATIONDRL2018-05-24
00850540007140Impulse 7010FLUKE ELECTRONICS CORPORATIONDRL2018-05-24
B418PHASE380004400DatrendDatrend Systems IncDRL2017-08-18
B223011403ZAP GUARDGUARDIAN ANGEL PRODUCTS INCDRL2017-03-14
B22391766ZAP GUARDGUARDIAN ANGEL PRODUCTS INCDRL2017-03-14
00863313000309BC Biomedical Defibrillator AnalyzerBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000316BC Biomedical Defibrillator AnalyzerBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000323BC Biomedical Defibrillator Analyzer Variable LoadBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000330Gossen Metrawatt SECULIFEBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000347Gossen Metrawatt SECULIFEBC GROUP INTERNATIONAL, INC.DRL2016-09-24
00863313000354Gossen Metrawatt SECULIFEBC GROUP INTERNATIONAL, INC.DRL2016-09-24