Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K151006
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K151006
Device Name
System,Network And Communication,Physiological Monitors
Applicant
EARLYSENSE LTD.
12 TZVI ST
RAMAT-GAN 5250429 IL
Other 510(k) Applications for this Company
Contact
DALIA ARGAMAN
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/2015
Decision Date
08/31/2015
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