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 electrocardiograph
510(k) Number K122356
FOIA Releasable 510(k) K122356
Device Name ALIVECOR HEART MONITOR FOR IPHONE
Applicant
ALIVECOR, INC.
140 GEARY STREET
SUITE 500
SAN FRANCISCO,  CA  94108
Applicant Contact MICHAEL RIGHTER
Correspondent
ALIVECOR, INC.
140 GEARY STREET
SUITE 500
SAN FRANCISCO,  CA  94108
Correspondent Contact MICHAEL RIGHTER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/03/2012
Decision Date 11/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-