510(k) K050800
K050800 is an FDA 510(k) premarket notification submitted by Caesarea Medical Electronics , Ltd. for the device "NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS". The FDA issued a decision of Substantially Equivalent on November 23, 2005. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Caesarea Medical Electronics , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2005
- Date Received
- March 30, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type