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, oxygen-uptake
510(k) Number K895935
Device Name ICOR CMU Q PLUS
Applicant
ICOR AB
ULVSUNDAVAGEN 178 B
BROMMA,  SE 161 30
Applicant Contact GEDEON, PHD
Correspondent
ICOR AB
ULVSUNDAVAGEN 178 B
BROMMA,  SE 161 30
Correspondent Contact GEDEON, PHD
Regulation Number868.1730
Classification Product Code
BZL  
Date Received10/11/1989
Decision Date 01/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-