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, imaging, pulsed doppler, ultrasonic
510(k) Number K230365
Device Name Sonio Detect
Applicant
Sonio
24 Rue du Faubourg Saint Jacques
Paris,  FR FR-75014
Applicant Contact Florian Akpakpa
Correspondent
Sonio
24 Rue du Faubourg Saint Jacques
Paris,  FR FR-75014
Correspondent Contact Florian Akpakpa
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
IYO   QIH  
Date Received02/10/2023
Decision Date 07/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-