Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-