Clearance Summary
MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM received FDA 510(k) clearance under submission number K060479, sponsored by Caesarea Medical Electronics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2006-05-12.
- Submission: K060479
- Applicant / Sponsor: Caesarea Medical Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2006-05-12
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.