510(k) K072988

NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 by Nipro Medical Corporation — Product Code FIB

K072988 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1". The FDA issued a decision of Substantially Equivalent on February 21, 2008. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2008
Date Received
October 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Transducer, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type