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 Injection Data Capture Device
510(k) Number K243901
Device Name SmartPilot YpsoMate NS-A2.25
Applicant
Ypsomed AG
Brunnmattstrasse 6
Burgdorf,  CH 3401
Applicant Contact Johannes Schmid
Correspondent
Ypsomed AG
Brunnmattstrasse 6
Burgdorf,  CH 3401
Correspondent Contact Johannes Schmid
Regulation Number880.5860
Classification Product Code
QOG  
Date Received12/19/2024
Decision Date 08/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-