Phoenix EEG Amplifier

GUDID B58804E0

EEG Amplifier

SOUTHEAST SIGNAL, INC

Multiple physiological signal amplifier Multiple physiological signal amplifier
Primary Device IDB58804E0
NIH Device Record Keyf3d5f522-1d83-405b-8591-e4b8e5023172
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhoenix EEG Amplifier
Version Model NumberA404
Company DUNS080546231
Company NameSOUTHEAST SIGNAL, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone352.289.0081
Emailsupport@sesig.net
Phone352.289.0081
Emailsupport@sesig.net

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB58804E0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-29

On-Brand Devices [Phoenix EEG Amplifier]

B58804E0EEG Amplifier
B58802E0EEG Amplifier

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