• 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 interoperable automated glycemic controller
510(k) Number K203774
Device Name SmartAdjust technology
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Alexander Hamad
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Katie Pacheco
Regulation Number862.1356
Classification Product Code
Date Received12/23/2020
Decision Date 01/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No