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 K943692
Device Name SMART DOSE(TM)
Applicant
River Medical, Inc.
7737 Kenamar Ct.
San Diego,  CA  92121
Applicant Contact MARK S HANNON
Correspondent
River Medical, Inc.
7737 Kenamar Ct.
San Diego,  CA  92121
Correspondent Contact MARK S HANNON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/28/1994
Decision Date 04/28/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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
-
-