FDA.reportPublic FDA data

Holter Analysis Software Apnea

Primary DI
M582NEMK1270
Brand
Holter Analysis Software Apnea
Company
Northeast Monitoring, Inc.
Model
Holter Analysis Software Apnea
Catalog number
M582NEMK127
Device description
Holter Analysis Software Apnea
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
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081861000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081861000HOLTER LX ANALYSISNorth East Monitoring, Inc.2008-12-04MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M582NEMK1270PrimaryHIBCC0

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
M581NEMK1620Holter Analysis SoftwareEnhanced PlusNEMK1622021-10-27
M581NEMK1630Holter Analysis SoftwareProNEMK1632021-10-27
M581NEMK1950LX EventLX Event ToolNEMK1952021-10-27
M581NEMK940DR200DR200 2LNEMK942021-10-27
M581NEMK950DR200DR200 5LNEMK952021-10-27
M581NEMK960DR200DR200 7LNEMK962021-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413407392Sensor kit for SOMNOscreen (paediatric)SOMNOmedics AGMNR2026-10-10
04250413407408Sensor kit for SOMNOscreen (extra small)SOMNOmedics AGMNR2026-10-10
04250413402380Pneumatic Effort Belt - Size XSSOMNOmedics AGMNR2026-10-09
04250413402397Pneumatic Effort Belt - Size SSOMNOmedics AGMNR2026-10-09
04250413402403Pneumatic Effort Belt - Size MSOMNOmedics AGMNR2026-10-09
04250413402410Pneumatic Effort Belt - Size LSOMNOmedics AGMNR2026-10-09
04250413402427Pneumatic Effort Belt - Size XXLSOMNOmedics AGMNR2026-10-09
04250413410392Wireless PLM/EMG sensor right legSOMNOmedics AGMNR2026-10-08
04250413401635DOMINO lightSOMNOmedics AGMNR2026-10-07
04250413402861EEG-ElectrodeSOMNOmedics AGMNR2026-10-07
04250413404858SOMNOtouch™ RESP ecoSOMNOmedics AGMNR2026-10-07
04250413405664DOMINOSOMNOmedics AGMNR2026-10-07
04250413410385Wireless PLM/EMG sensor left legSOMNOmedics AGMNR2026-10-07
00850063034395Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034500Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00850063034517Night ShiftADVANCED BRAIN MONITORING, INC.MNR2026-10-05
00860000272421Rhythm ExpressVIVAQUANT, INC.MNR2026-10-01
08885021950075TipTraQPRANAQ PTE. LTD.MNR2026-09-25
08885021950105TipTraQPRANAQ PTE. LTD.MNR2026-09-25
04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
04250413406388SOMNOwatch™ eco orangeSOMNOmedics AGMNR2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGMNR2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGMNR2026-07-02
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15