K837139Substantially Equivalent
Models Eurosun 2400 and 800
Eurosun Scaenda Sol, Walker MI / Traditional, Substantially Equivalent
K837139 is the FDA 510(k) clearance record for MODELS EUROSUN 2400 AND 800, cleared for Eurosun Scaenda Sol on . FDA records list one 510(k) clearance for Eurosun Scaenda Sol. As of , FDA records show no recalls naming K837139.
Clearance record
- Decision date
- Received
- (52 days to decision)
- Review panel
- Unknown
- Applicant
- Eurosun Scaenda Sol 4221 Richmond Rd., NW, Walker MI
- Third party review
- No
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.