Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181823
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K181823
Device Name
Computer, Diagnostic, Programmable
Applicant
AliveCor, Inc.
444 Castro Street, Suite 600
Mountain View, CA 94041 US
Other 510(k) Applications for this Company
Contact
Prabhu Raghavan
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2018
Decision Date
03/11/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact