510(k) K072988
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