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, Ac-Powered
510(k) Number K190382
Device Name Intraocular Pressure Tonometer EASYTON
Applicant
Company Elamed
Yelatma Instrument-Making Enterprise, Jsc
391351, 25 Janina St.,
Yelatma,  RU
Applicant Contact Mikhail Kuzin
Correspondent
Company Elamed
Yelatma Instrument-Making Enterprise, Jsc
391351, 25 Janina St.,
Yelatma,  RU
Correspondent Contact Mikhail Kuzin
Regulation Number886.1930
Classification Product Code
HKX  
Date Received02/19/2019
Decision Date 12/06/2019
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
-
-