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FDA 510(k) Application Details - K111854
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K111854
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
ST. JUDE MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA SE-751 35 SE
Other 510(k) Applications for this Company
Contact
MIKAEL SJOLANDER
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
06/29/2011
Decision Date
10/21/2011
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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