• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name electrocardiograph
510(k) Number K082173
Device Name Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
Original Applicant
CARDIAC SCIENCE CORPORATION
3303 monte villa pkwy.
bothell,  WA  98021
Original Contact beverly magrane
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/01/2008
Decision Date 08/26/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-