510(k) K093976

RAISIN PERSONAL MONITOR by Proteus Biomedical, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2010
Date Received
December 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type