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 Infusor, Pressure, For I.V. Bags
510(k) Number K974074
Device Name INFUSION DYNAMICS POWER INFUSER
Applicant
Infusion Dynamics, Inc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Applicant Contact THOMAS BECZE
Correspondent
Infusion Dynamics, Inc.
116 Village Blvd., Suite 200
Princeton,  NJ  08540
Correspondent Contact THOMAS BECZE
Regulation Number880.5420
Classification Product Code
KZD  
Date Received10/29/1997
Decision Date 02/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-