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TPLC
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Device
amplifier, physiological signal
Regulation Description
Physiological signal amplifier.
Product Code
GWL
Regulation Number
882.1835
Device Class
2
Premarket Reviews
Manufacturer
Decision
BLACKROCK MICROSYSTEMS
SUBSTANTIALLY EQUIVALENT
1
BRAINMATTERZ, LLC
SUBSTANTIALLY EQUIVALENT
1
CGX, LLC
SUBSTANTIALLY EQUIVALENT
1
DORMOTECH MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
EB NEURO S.P.A.
SUBSTANTIALLY EQUIVALENT
2
1. K242305
BE Plus PRO, Neurotravel LIGHT
2. K242832
NExT Station; NExT Station Advanced
HIPPOSCREEN NEUROTECH CORP.
SUBSTANTIALLY EQUIVALENT
1
NEUROTRONICS, INC.
SUBSTANTIALLY EQUIVALENT
1
SOMNOMED TECHNOLOGIES INC., DOING BUSINESS AS REMWARE
SUBSTANTIALLY EQUIVALENT
1
X-TRODES
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1
1
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