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 K942162
Device Name SIGMA 8000 AND SIGMA 8002
Applicant
Sigma Intl.
11020 W. Center St. Ext
Medina,  NY  14103
Applicant Contact CHARLES MARTINA
Correspondent
Sigma Intl.
11020 W. Center St. Ext
Medina,  NY  14103
Correspondent Contact CHARLES MARTINA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/04/1994
Decision Date 10/20/1994
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
-
-