510(k) K023883
K023883 is an FDA 510(k) premarket notification submitted by I-Flow Corp. for the device "HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO". The FDA issued a decision of Substantially Equivalent on December 20, 2002. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. I-Flow Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2002
- Date Received
- November 21, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Elastomeric
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type