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
510(k) Number K830038
Device Name SIGMA 7000-6000 INFUSION PUMPS
Applicant
Sigma
14 Elizabeth St.
Middleport,  NY  14105
Applicant Contact ROGER L HUNGERFORD
Correspondent
Sigma
14 Elizabeth St.
Middleport,  NY  14105
Correspondent Contact ROGER L HUNGERFORD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/18/1983
Decision Date 01/26/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-