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FDA 510(k) Application Details - K101178
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K101178
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
INTEL CORP.
1900 PRAIRIE CITY RD., FM7-197
FOLSOM, CA 95630 US
Other 510(k) Applications for this Company
Contact
MAUREEN GLYNN
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
04/27/2010
Decision Date
06/29/2010
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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