MyoVision Software

GUDID 00853818007057

Software

PRECISION BIOMETRICS INC

Bioelectrical signal analysis software
Primary Device ID00853818007057
NIH Device Record Key96a19fab-0fc6-4817-9bb8-7aa4dd8e3d3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoVision Software
Version Model NumberApricot
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
GS100853818007057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQXGoniometer, Ac-Powered

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

On-Brand Devices [MyoVision Software]

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00853818007101Software
00853818007095Software
00853818007088Software
00853818007071Software
00853818007064Software
00853818007057Software
00853818007477Software

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