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FDA 510(k) Application Details - K091220
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K091220
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY
515 LEGGET DRIVE SUITE 700
OTTAWA K2K 3G4 CA
Other 510(k) Applications for this Company
Contact
SHAWN SLADE
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
04/27/2009
Decision Date
09/21/2009
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
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