FDA.reportPublic FDA data

DR200

Primary DI
M581NEMK950
Brand
DR200
Company
Northeast Monitoring, Inc.
Model
DR200 5L
Catalog number
NEMK95
Device description
DR200 holter recorder w/ 5L patient cable
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
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061293000TELAHEART DIGITAL RECORDERNorth East Monitoring, Inc.2006-08-25MWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M581NEMK950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording analyserAn electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth2Centimeter
Length8.6Centimeter
Weight70.9Gram
Width6Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00allowed storage conditions: -40C to 70C

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
837441815
Device count
1
Serial number
true
Manufacturing date on label
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
M581NEMK960DR200DR200 7LNEMK962021-10-27
M582NEMK1270Holter Analysis Software ApneaHolter Analysis Software ApneaM582NEMK1272021-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250903203381CardioMem getemed Medizin- und Informationstechnik AGMWJ2026-05-01
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.MWJ2025-12-17
10841522131349Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131356Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131363Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131387Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131394Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131400Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131370Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-01
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
B353UB12511UbiqVue HolterLifesignals, Inc.MWJ2025-04-22
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.MWJ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.MWJ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.MWJ2025-04-02
00860004541745ANNE ChestSibel Health Inc.MWJ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.MWJ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.MWJ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.MWJ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.MWJ2025-03-26
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04