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 K211355
Device Name iCare HOME2
Applicant
Icare Finland Oy
Ayritie 22
Vantaa,  FI 01510
Applicant Contact Hannes Hyvönen
Correspondent
Icare Finland Oy
Ayritie 22
Vantaa,  FI 01510
Correspondent Contact Hannes Hyvönen
Regulation Number886.1930
Classification Product Code
HKY  
Date Received05/03/2021
Decision Date 01/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-