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 Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K865101
Device Name SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
Applicant
Spectramed, Inc.
2530 Pennsylvania Ave. S.
St. Louis Park,  MN  55426
Applicant Contact FREEDMAN, PHD
Correspondent
Spectramed, Inc.
2530 Pennsylvania Ave. S.
St. Louis Park,  MN  55426
Correspondent Contact FREEDMAN, PHD
Regulation Number870.1435
Classification Product Code
DXG  
Date Received12/30/1986
Decision Date 04/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-