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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K172492
Device Name Optical Topography System ETG-4100
Applicant
Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg,  OH  44087
Applicant Contact Doug Thistlethwaite
Correspondent
Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg,  OH  44087
Correspondent Contact Doug Thistlethwaite
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/17/2017
Decision Date 08/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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