Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K120536
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K120536
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
HEART SYNC INC.
8870 RAVELLO CT
NAPLES, FL 34114 US
Other 510(k) Applications for this Company
Contact
DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number
870.5310
More FDA Info for this Regulation Number
Classification Product Code
MKJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/22/2012
Decision Date
08/06/2012
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