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 Tonometer, Manual
510(k) Number K133234
Device Name T-TYPE D-KAT, R-TYPE D-KAT
Applicant
Keeler Limited
456 Pkwy.
Broomall,  PA  19008
Applicant Contact EUGENE R VANARSDALE
Correspondent
Keeler Limited
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact EUGENE R VANARSDALE
Regulation Number886.1930
Classification Product Code
HKY  
Date Received10/21/2013
Decision Date 02/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-