FDA.reportPublic FDA data

Holter Analysis Software

Primary DI
M581NEMK1620
Brand
Holter Analysis Software
Company
Northeast Monitoring, Inc.
Model
Enhanced Plus
Catalog number
NEMK162
Device description
Holter Analysis Enhanced Plus
Published
2021-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930564000HOLTER FOR WINDOWSNorth East Monitoring, Inc.1995-04-19DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M581NEMK1620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac arrhythmia monitoring systemAn assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
837441815
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M581NEMK1290DR200DR200 3LNEMK1292021-10-27
M581NEMK1380DR181DR181 5LNEMK1382021-10-27
M581NEMK1390DR181DR181 7LNEMK1392021-10-27
M581NEMK1400DR181DR181 12L2021-10-27
M581NEMK1540DR300DR300 5LNEMK1542021-10-27
M581NEMK1550DR300DR300 7LNEMK1552021-10-27
M581NEMK1560GatewayGatewayNEMK1562021-10-27
M581NEMK1570DR400DR400NEMK1572021-10-27
M581NEMK1600Holter Analysis SoftwareBasicNEMK1602021-10-27
M581NEMK1610Holter Analysis SoftwareEnhancedNEMK1612021-10-27
M581NEMK1630Holter Analysis SoftwareProNEMK1632021-10-27
M581NEMK1950LX EventLX Event ToolNEMK1952021-10-27
M581NEMK940DR200DR200 2LNEMK942021-10-27
M581NEMK950DR200DR200 5LNEMK952021-10-27
M581NEMK960DR200DR200 7LNEMK962021-10-27
M582NEMK1270Holter Analysis Software ApneaHolter Analysis Software ApneaM582NEMK1272021-10-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00199874185187Vektor Medical vMap SoftwareVektor Medical, Inc.DQK2026-05-08
00195278620873MACGe Medical Systems Information Technologies, Inc.DQK2026-03-31
00195278507037Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-03-26
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00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDQK2025-12-09
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
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08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
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08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
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17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDQK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDQK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDQK2023-04-19
00195278524089NAGE Healthcare Finland OyDQK2023-04-19