510(k) K061325
K061325 is an FDA 510(k) premarket notification submitted by Caesarea Medical Electronics , Ltd. for the device "BODYGAURD PAIN MANAGER INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 24, 2006. 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
- August 24, 2006
- Date Received
- May 11, 2006
- Clearance Type
- Abbreviated
- 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