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TPLC
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show TPLC since
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Device
stimulator, photic, evoked response
Product Code
GWE
Regulation Number
882.1890
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANSCHEL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
CRYPTYCH PTY LTD
SUBSTANTIALLY EQUIVALENT
1
DIAGNOSYS LLC
SUBSTANTIALLY EQUIVALENT
1
DIOPSYS INC.
SUBSTANTIALLY EQUIVALENT
1
LIFELINES LTD.
SUBSTANTIALLY EQUIVALENT
1
LKC TECHNOLOGIES, INC
SUBSTANTIALLY EQUIVALENT
1
METROVISION
SUBSTANTIALLY EQUIVALENT
2
1. K211643
Vision Monitor - MonpackONE
2. K212936
Vision Monitor- MonCvONE
MICROMED S.P.A.
SUBSTANTIALLY EQUIVALENT
1
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
SUBSTANTIALLY EQUIVALENT
1
VERISCI CORPORATION
SUBSTANTIALLY EQUIVALENT
1
VISIONSEARCH PTY LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2016
2
2
2018
2
2
2022
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Sparking
4
4
Thermal Decomposition of Device
2
2
Electrical /Electronic Property Problem
2
2
Material Frayed
2
2
Adverse Event Without Identified Device or Use Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
4
4
No Clinical Signs, Symptoms or Conditions
2
2
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Diopsys, Inc.
III
Apr-26-2010
2
Natus Medical Incorporated
II
Feb-09-2015
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