FDA.reportPublic FDA data

Central Station

Primary DI
00851725007399
Brand
Central Station
Company
Nihon Kohden Digital Health Solutions, LLC
Model
CNSCS-001
Device description
Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters.
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRQAmplifier And Signal Conditioner, Transducer Signal
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MSXSystem, Network And Communication, Physiological Monitors
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRQAmplifier And Signal Conditioner, Transducer SignalCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242750000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242750000Central StationNihon Kohden Digital Health Solutions, LLC2025-06-05MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851725007399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851725007399008517250073998517250073990851725007399

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(949) 474-9207info@nkdhs.com

Regulatory Flags#

DUNS number
126381560
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851725007368NetKonnect CentralNKCNS-0012026-03-31
00851725007351Next Generation NetKonnectNGNK-6801NGNK-68012023-06-05
00851725007115Next Generation NetKonnectNGNK-6803-MNGNK-6803-M2022-08-31
00851725007306Next Generation NetKonnectNGNK-6803NGNK-68032022-08-31
00851725007313Next Generation NetKonnectNGNK-6804NGNK-68042022-08-31
00851725007320Next Generation NetKonnectNGNK-6803-TNGNK-6803-T2022-08-31
00851725007337Next Generation NetKonnectNGNK-6804-MNGNK-6804-M2022-08-31
00851725007344Next Generation NetKonnectNGNK-6804-TNGNK-6804-T2022-08-31
00851725007269Remote Network StationRNS-6804-7490-URNS-6804-7490-U2021-09-30
00851725007276Remote Network StationRNS-6803-7490-URNS-6803-7490-U2021-09-30
00851725007283Remote Network StationRNS-6804-7490RNS-6804-74902021-09-30
00851725007290Remote Network StationRNS-6803-7490RNS-6803-74902021-09-30
00851725007245Remote Network StationRNS-6804-7480-URNS-6804-7480-U2021-05-26
00851725007252Remote Network StationRNS-6803-7480-URNS-6803-7480-U2021-05-26
00851725007221Remote Network StationRNS-6804-7480RNS-6804-74802020-12-23
00851725007238Remote Network StationRNS-6803-7480RNS-6803-74802020-12-23
00851725007214PrefenseEDNS-9001-AVGH977EDNS-9001-AVGH9772020-10-31
00851725007177Remote Network StationRNS-6804-7460RNS-6804-74602020-03-25
00851725007184Remote Network StationRNS-6803-7460RNS-6803-74602020-03-25
00851725007191Remote Network StationRNS-6803-7470RNS-6803-74702020-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675786320Infinity M540DRAEGER MEDICAL SYSTEMS, INC.MHX2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHMHX2026-10-21
00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-07-21
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612161049FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612209543FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17