Eclipse System— 510(k) K150558
Substantially EquivalentPelvalon, Inc.
FDA 510(k) clearance K150558 for Eclipse System, Substantially Equivalent on 2015-11-12. Applicant: Pelvalon, Inc.. Device class: 2.
Clearance details
- Applicant
- Pelvalon, Inc.
- Product code
- Code PJH
- Device class
- Class 2
- Regulation
- 21 CFR 876.5930
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code PJH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.