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 electrocardiograph
510(K) Number K121009
Model HCEKGP10
Device Name HEARTCHECK ECG PEN WITH GEMS HOME
Applicant
CARDIO COMM SOLUTIONS, INC.
962 allegro lane
apollo beach,  FL  33572
Contact jonathan ward
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/03/2012
Decision Date 05/17/2012
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
-
-