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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Attention Task Performance
510(k) Number K861304
Device Name FAGAN TEST MACHINE FOR INFANT INTELLIGENCE
Applicant
INFANTEST CORP.
2579 NORTH MORELAND,
BLDG. D, SUITE 1
SHAKER HEIGHTS,  OH  44120
Applicant Contact JOSEPH FAGAN
Correspondent
INFANTEST CORP.
2579 NORTH MORELAND,
BLDG. D, SUITE 1
SHAKER HEIGHTS,  OH  44120
Correspondent Contact JOSEPH FAGAN
Classification Product Code
LQD  
Date Received04/07/1986
Decision Date 09/23/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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