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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(K) Number K093422
Model 5000 SERIES
Device Name VITAL SYNC MODEL 5000 SERIES
Applicant
SOMANETICS CORP.
1653 east maple rd.
troy,  MI  48083 4208
Contact ronald a widman
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/03/2009
Decision Date 04/29/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-