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 K930495
Device Name PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP
Applicant
Elan Medical Technologies, Ltd.
1300 Gould Dr.
Gainesville,  GA  30504
Applicant Contact PATRICK COLLIER
Correspondent
Elan Medical Technologies, Ltd.
1300 Gould Dr.
Gainesville,  GA  30504
Correspondent Contact PATRICK COLLIER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/01/1993
Decision Date 04/26/1994
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
-
-