Live View Panel Version 1.3

GUDID 00817111020786

Live View Panel Version 1.3

NEUROTRONICS, INC.

Bioelectrical signal analysis software
Primary Device ID00817111020786
NIH Device Record Keyca2333e4-44cb-4dd4-af3d-39862c6bce9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLive View Panel Version 1.3
Version Model Number1.3
Company DUNS036405363
Company NameNEUROTRONICS, 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817111020786 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-12-11
Device Publish Date2016-09-22

Devices Manufactured by NEUROTRONICS, INC.

00817111021172 - Polysmith Version 12.02020-04-09
00817111020748 - Polysmith Version 10.02019-12-11
00817111020755 - Polysmith Version 9.02019-12-11
00817111020779 - Polysmith Version 11.02019-12-11
00817111020786 - Live View Panel Version 1.32019-12-11Live View Panel Version 1.3
00817111020786 - Live View Panel Version 1.32019-12-11 Live View Panel Version 1.3
00817111020816 - Live View Panel Version 1.42019-12-11 Live View Panel Version 1.4
00817111021141 - Nomad PMU800 Portable Recorder (USB)2019-05-09 Nomad PMU800 Portable Recorder (USB)
00817111021158 - Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m2019-05-09 Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m

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