MyoVision Software

GUDID 00853818007064

Software

PRECISION BIOMETRICS INC

Bioelectrical signal analysis software
Primary Device ID00853818007064
NIH Device Record Key58c9a3fd-c7d7-4502-bee0-29f0875111ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoVision Software
Version Model NumberFeature Pack A
Company DUNS362997926
Company NamePRECISION BIOMETRICS 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
GS100853818007064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IKNElectromyograph, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-12
Device Publish Date2016-11-27

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