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FDA 510(k) Application Details - K101078
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K101078
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
BL HEALTHCARE, INC.
33 COMMERCIAL ST., SUITE #3
FOXBORO, MA 02035 US
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Contact
MICHAEL MATHUR
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
04/19/2010
Decision Date
05/10/2010
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
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