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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, galvanic skin response measurement
Regulation Description Galvanic skin response measurement device.
Product CodeGZO
Regulation Number 882.1540
Device Class 2


Premarket Reviews
ManufacturerDecision
IMPETO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LD TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDEIA, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Inappropriate Shock 5
Protective Measures Problem 2
Installation-Related Problem 2
Total Device Problems 9

Recalls
Manufacturer Recall Class Date Posted
1 Hudson Scientific LLC II Aug-08-2018
2 ZYTO Technologies, Inc. II Jul-01-2016

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