Easy Ambulatory

GUDID 00840067100455

Easy Ambulatory Recorder

CADWELL INDUSTRIES, INC.

Electroencephalograph
Primary Device ID00840067100455
NIH Device Record Key71f81e82-acfd-4c11-a18b-10a8ae24881f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy Ambulatory
Version Model Number190206-200
Company DUNS098554157
Company NameCADWELL INDUSTRIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com
Phone+1(509)735-6481
Emailapplications@cadwell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840067100455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-14
Device Publish Date2016-09-05

On-Brand Devices [Easy Ambulatory]

00840067100660Easynet Ambulatory Microphone
0084006710059232 Ch EEG EasyNet Amplifier
00840067100585Q-Video Mobile 2
00840067100455Easy Ambulatory Recorder

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