Ochs Labs EEG Amplifier

GUDID B58802L0

EEG Amplifier

SOUTHEAST SIGNAL, INC

Multiple physiological signal amplifier Multiple physiological signal amplifier
Primary Device IDB58802L0
NIH Device Record Key02ac2aea-61a6-4fca-b727-8217db193d76
Commercial Distribution StatusIn Commercial Distribution
Brand NameOchs Labs EEG Amplifier
Version Model NumberA200
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
HIBCCB58802L0 [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

Devices Manufactured by SOUTHEAST SIGNAL, INC

B58802E0 - Phoenix EEG Amplifier2018-07-06 EEG Amplifier
B58802L0 - Ochs Labs EEG Amplifier2018-07-06EEG Amplifier
B58802L0 - Ochs Labs EEG Amplifier2018-07-06 EEG Amplifier
B58804E0 - Phoenix EEG Amplifier2018-07-06 EEG Amplifier

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