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 system, x-ray, tomography, computed
510(k) Number K213465
Device Name CardioGraphe
Applicant
Arineta Ltd.
15 Halamish Street
Caesarea,  IL 3088900
Applicant Contact Tanya Shalem
Correspondent
Arineta Ltd.
15 Halamish Street
Caesarea,  IL 3088900
Correspondent Contact Tanya Shalem
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/28/2021
Decision Date 12/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-