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FDA 510(k) Application Details - K002834
Device Classification Name
Perineometer
More FDA Info for this Device
510(K) Number
K002834
Device Name
Perineometer
Applicant
SRS MEDICAL SYSTEMS, INC.
14950 N.E. 95TH ST.
REDMOND, WA 98052 US
Other 510(k) Applications for this Company
Contact
LEE BRODY
Other 510(k) Applications for this Contact
Regulation Number
884.1425
More FDA Info for this Regulation Number
Classification Product Code
HIR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/12/2000
Decision Date
11/29/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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