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 K961263
Device Name MODEL 1200 ABMULATORY INFUSION PUMP
Applicant
Patient Solutions, Inc.
13220 Evening Creek Dr. So.,
Suite 114
San Diego,  CA  92128
Applicant Contact TOM KANE
Correspondent
Patient Solutions, Inc.
13220 Evening Creek Dr. So.,
Suite 114
San Diego,  CA  92128
Correspondent Contact TOM KANE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/02/1996
Decision Date 08/23/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-