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FDA 510(k) Application Details - K031169
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
510(K) Number
K031169
Device Name
System, Gastrointestinal Motility (Electrical)
Applicant
SIERRA SCIENTIFIC INSTRUMENTS, INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO, CA 92128 US
Other 510(k) Applications for this Company
Contact
SEAN M CURRY
Other 510(k) Applications for this Contact
Regulation Number
876.1725
More FDA Info for this Regulation Number
Classification Product Code
FFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2003
Decision Date
12/12/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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