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 E. River Rd.
Suite 312
Minneapolis,  MN  55421 -1014
Applicant Contact JIM MYERS
Correspondent
Disetronic Medical Systems
5201 E. 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
Predetermined Change
Control Plan Authorized		 No
-
-