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 Monitor, Eye Movement
510(k) Number K872111
Device Name ORTHOTONE
Applicant
Orthotone Corp.
201 E. 28th St., Suite 6-F
New York,  NY  10016
Applicant Contact JOHN ORZUCHOWSKI
Correspondent
Orthotone Corp.
201 E. 28th St., Suite 6-F
New York,  NY  10016
Correspondent Contact JOHN ORZUCHOWSKI
Regulation Number886.1510
Classification Product Code
HLL  
Date Received06/01/1987
Decision Date 11/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-