Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100508
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K100508
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
CAREMATIX INC.
209 W. JACKSON BLVD.
SUITE 800
CHICAGO, IL 60606 US
Other 510(k) Applications for this Company
Contact
SUKHWANT KHANUJA
Other 510(k) Applications for this Contact
Regulation Number
870.2910
More FDA Info for this Regulation Number
Classification Product Code
DRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/22/2010
Decision Date
05/05/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact