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 alternate controller enabled insulin infusion pump
510(k) Number K213536
Device Name DEKA ACE Pump System
Applicant
DEKA Research and Development
340 Commercial Street
Manchester,  NH  03101
Applicant Contact Paul Smolenski
Correspondent
DEKA Research and Development
340 Commercial Street
Manchester,  NH  03101
Correspondent Contact Paul Smolenski
Regulation Number880.5730
Classification Product Code
QFG  
Subsequent Product Code
NDC  
Date Received11/05/2021
Decision Date 07/25/2023
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
-
-