SEN-4100A

GUDID 04931921105313

Electric Simulator

NIHON KOHDEN CORPORATION

Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system
Primary Device ID04931921105313
NIH Device Record Key72823d4e-b0de-4f71-8759-56d958258b76
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSEN-4100A
Catalog NumberSEN-4100A
Company DUNS690568050
Company NameNIHON KOHDEN CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com
Phone+1(800)325-0283
Emailinfo@nkusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104931921105313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-05

Devices Manufactured by NIHON KOHDEN CORPORATION

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04931921007730 - Nihon Kohden, EEG-1200A Series Neurofax2023-10-09 Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
04931921017166 - CNS-2101 Central Monitor2023-10-09 Central Monitor
04931921010235 - cap-ONE2023-05-30 cap-ONE Nasal Adapter, Adult
04931921010273 - cap-ONE2023-05-30 cap-ONE Nasal Adapter, Adult, w/ Oxygen tube
04931921010303 - cap-ONE2023-05-30 cap-ONE Nasal Adapter, Pediatric
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