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 Camera, Ophthalmic, Ac-Powered
510(k) Number K221329
Device Name Eyer Retinal Camera NM-STD
Applicant
Phelcom Technologies
Rua José Missali, 820 - Santa Felícia
São Carlos,  BR 13562-405
Applicant Contact Flávio Pascoal Vieira
Correspondent
Passarini Regulatory Affairs of America, LLC
201, S. Biscayne Blvd., Suite 1200
Miami,  FL  33131
Correspondent Contact Bruno Milhoci de Souza
Regulation Number886.1120
Classification Product Code
HKI  
Date Received05/06/2022
Decision Date 02/22/2023
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
-
-