ATLAS COMBO BOARD 31-0605-0117

GUDID 00850011306147

The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-36 Board onto a single board, meaning the Digital Reference Selection and Analog to Digital Conversion for 32 electrodes is combined into a single slot.

NEURALYNX, INC.

Electroencephalographic monitoring system
Primary Device ID00850011306147
NIH Device Record Keyf18a0497-1704-40ce-9ad6-08c17c62d113
Commercial Distribution StatusIn Commercial Distribution
Brand NameATLAS COMBO BOARD
Version Model NumberATLAS COMBO BOARD
Catalog Number31-0605-0117
Company DUNS933200842
Company NameNEURALYNX, 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 Usefalse
Lot Batchfalse
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

Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com
Phone4065854542
Emailsupport@neuralynx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011306147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMCReduced- Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-12
Device Publish Date2020-02-27

On-Brand Devices [ATLAS COMBO BOARD]

10850011306144The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-3
00850011306147The ATLAS Combo Board combines the functionality of the ATLAS Hybrid Input Board and ATLAS DRS-3

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