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 Controller, Infusion, Intravascular, Electronic
510(k) Number K863204
Device Name DEKA JR.
Applicant
Deka Research & Development Corp.
Technology Center, 340 Commercial St.
Manchester,  NH  03101
Applicant Contact STEPHEN W SAGON
Correspondent
Deka Research & Development Corp.
Technology Center, 340 Commercial St.
Manchester,  NH  03101
Correspondent Contact STEPHEN W SAGON
Regulation Number880.5725
Classification Product Code
LDR  
Date Received08/19/1986
Decision Date 09/03/1986
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
-
-