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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device amplifier, physiological signal
Product CodeGWL
Regulation Number 882.1835
Device Class 2


Premarket Reviews
ManufacturerDecision
BLACKROCK MICROSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BRAINMATTERZ, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 209, INC.
  SUBSTANTIALLY EQUIVALENT 1
CGX, LLC
  SUBSTANTIALLY EQUIVALENT 1
DORMOTECH MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
EB NEURO, S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
EMS HANDELS GESELLSCHAFT M.B.H.
  SUBSTANTIALLY EQUIVALENT 1
G.TEC MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 2
HIPPOSCREEN NEUROTECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
I2S MICRO IMPLANTABLE SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFELINES LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROMETRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
X-TRODES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 1 1
Overheating of Device 1 1
Peeled/Delaminated 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Blackrock Microsystems, LLC II Sep-08-2016
2 I2s Micro Implantable Systems Llc II May-20-2010
3 Natus Neurology Incorporated II Mar-13-2013
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