• 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 K060167
Device Name ATRIA 3100, ATRIA 6100
Original Applicant
CARDIAC SCIENCE CORPORATION
3303 monte villa pkwy.
bothell,  WA  98021
Original Contact cheryl shea
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/23/2006
Decision Date 04/19/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-