510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nihon Kohden Corp.

Shinjuku-Ku, JP

NIHON KOHDEN CORP. appears in FDA device records in Shinjuku-Ku, JP. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
31
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 31 510(k) clearances for Nihon Kohden Corp. between 2010 and 2026. The busiest year on record is 2017, with 5. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Nihon Kohden Corp., by decision year
YearClearances
20102
20114
20122
20131
20153
20162
20175
20192
20201
20213
20221
20231
20252
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251641GF-310R Multigas Unit (GF-310R)CCKSubstantially Equivalent
K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffDXQSubstantially Equivalent
K251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)OLTSubstantially Equivalent
K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCKSubstantially Equivalent
K223567CNS-2101 Central MonitorMSXSubstantially Equivalent
K220976Life Scope PT BSM-1700 Series Bedside MonitorKOISubstantially Equivalent
K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMKOISubstantially Equivalent
K203435Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring SystemMHXSubstantially Equivalent
K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesKOISubstantially Equivalent
K191975Elefix V Paste for EEG & EMGGYBSubstantially Equivalent
K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorMWISubstantially Equivalent
K183529AE-120A EEG Head SetOMCSubstantially Equivalent
K171765Nihon Kohden CO2 MonitorCCKSubstantially Equivalent
K171124Nihon Kohden Wireless Input Unit WEE-1200GWQSubstantially Equivalent
K163644Nihon Kohden QP-160AK EEG Trend ProgramOMASubstantially Equivalent
K163459Nihon Kohden Vital Sign TelemeterMHXSubstantially Equivalent
K161860TG-970P CO2 Sensor KitCCKSubstantially Equivalent
K153707Nihon Kohden Vital Sign TelemeterMHXSubstantially Equivalent
K152305Nihon Kohden Afib Detection Program QP-039PDSISubstantially Equivalent
K151080Nihon Kohden CSM 1901 Bedside MonitorMHXSubstantially Equivalent
K142624Neuromaster G1 MEE200GWFSubstantially Equivalent
K130238NIHON KOHDEN AE-918P NEURO UNITOMASubstantially Equivalent
K122214TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)CCKSubstantially Equivalent
K120888PSG-1100 SLEEP DIAGNOSTIC SYSTEMGWQSubstantially Equivalent
K120397MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEMGWFSubstantially Equivalent
K112637NETKONNECT REMOTE NETWORK EXTENSIONMHXSubstantially Equivalent
K110594GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORSCCKSubstantially Equivalent
K110410MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)GYCSubstantially Equivalent
K110376PE-210AK SWITCH BOXGWQSubstantially Equivalent
K102106NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATIONDRGSubstantially Equivalent
K102376NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201MHXSubstantially Equivalent

Registered establishments

FDA registered establishments for Nihon Kohden Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96112523002807720NIHON KOHDEN CORP.31-4 NISHIOCHIAI, 1-CHOME,, SHINJUKU-KU Tokyo 161-8560 JP2026and 38 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain