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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, hearing aid / earphone and analysis systems
Regulation Description Hearing aid calibrator and analysis system.
Product CodeETW
Regulation Number 874.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BIO-LOGIC SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
GN OTOMETRICS A/S
  SUBSTANTIALLY EQUIVALENT 2
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
STARKEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 4

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