Clearance Summary
MODIFICATION TO: BODYGUARD INFUSION SYSTEM received FDA 510(k) clearance under submission number K070718, sponsored by Caesarea Medical Electronics , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-04-13.
- Submission: K070718
- Applicant / Sponsor: Caesarea Medical Electronics , Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2007-04-13
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.