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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tester, auditory impedance
Product CodeETY
Regulation Number 874.1090
Device Class 2


Premarket Reviews
ManufacturerDecision
DB DIAGNOSTIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC GROUP, DBA GRASON-STADLER
  SUBSTANTIALLY EQUIVALENT 1
GN OTOMETRICS
  SUBSTANTIALLY EQUIVALENT 1
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 2
INTERACOUSTICS AS
  SUBSTANTIALLY EQUIVALENT 1
INVENTIS SRL
  SUBSTANTIALLY EQUIVALENT 1
MAICO DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Heating 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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