SEN-4100A

GUDID 00841983101427

Electric Simulator

NIHON KOHDEN AMERICA, INC.

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 ID00841983101427
NIH Device Record Key1d51c1da-cdfd-4c09-9853-f6dc5d52479d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSEN-4100A
Catalog NumberSEN-4100A
Company DUNS021063219
Company NameNIHON KOHDEN AMERICA, INC.
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
GS100841983101427 [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 Date2016-09-19

Devices Manufactured by NIHON KOHDEN AMERICA, INC.

10841983103947 - NA2023-10-09 PAPER, ECG1250, 9020, 10 PADS
10841983103954 - NA2023-10-09 PAPER, ECG1350, 9130, 10 PADS
10841983103930 - NA2023-08-17 PAPER, ECG-1550A, 10 PADS
00841983104336 - NK-HealthProtect Wireless Surge Solution2021-12-31 Wireless Surge Solution, field deployable ambulatory monitoring of up to 8 patients with pop-up central monitoring
10841983102667 - NA2021-11-10 SpO2 probe Adults, child (from 15 to 50 kg) Finger, disposable
10841983102674 - NA2021-11-10 SpO2 probe Child, infant (from 3 to 15 kg) Toe, disposable
10841983102704 - BluPRO®2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 80cm cable
10841983102711 - BluPRO®2021-11-10 SpO2 probe Adults (30 kg or more) Finger or toe, disposable, 160cm cable
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