Proprietary Name: AliveCor ECG; AliveCor ECG for iPhone; AliveCor Heart Monitor; AliveCor Heart Monitor for iPhone; AliveCor Heart Monitor for iPhone 4/4S; AliveCor Heart Monitor for iPhone 5
Classification Name: ELECTROCARDIOGRAPH
Product Code: DPS
Device Class: 2
Regulation Number: 870.2340
Medical Specialty: Cardiovascular
Registered Establishment Name: AliveCor
Registered Establishment Number: 3009715978
Premarket Submission Number: K122356
Owner/Operator: AliveCor, Inc.
Owner/Operator Number: 10041430
Establishment Operations: Specification Developer; Complaint File Establishment