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 pump, infusion, insulin
510(k) Number K973044
Device Name DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
Applicant
DISETRONIC MEDICAL SYSTEMS
5201 EAST RIVER RD.
SUITE 312
MINNEAPOLIS,  MN  55421 -1014
Applicant Contact JIM MYERS
Correspondent
DISETRONIC MEDICAL SYSTEMS
5201 EAST RIVER RD.
SUITE 312
MINNEAPOLIS,  MN  55421 -1014
Correspondent Contact JIM MYERS
Regulation Number880.5725
Classification Product Code
LZG  
Date Received08/15/1997
Decision Date 09/15/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-