• 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 Ophthalmoscope, Ac-Powered
510(k) Number K881984
Device Name EOL, MODEL LIO
Applicant
EOL, INC.
701 SCARBORO RD.
OAK RIDGE,  TN  37830
Applicant Contact ROGER LEACH
Correspondent
EOL, INC.
701 SCARBORO RD.
OAK RIDGE,  TN  37830
Correspondent Contact ROGER LEACH
Regulation Number886.1570
Classification Product Code
HLI  
Date Received05/12/1988
Decision Date 09/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-