iOrtho— 510(k) K223518
Substantially EquivalentShanghai EA Medical Instruments Co., Ltd.
FDA 510(k) clearance K223518 for iOrtho, Substantially Equivalent on 2023-06-13. Applicant: Shanghai EA Medical Instruments Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai EA Medical Instruments Co., Ltd.
- Product code
- Code PNN
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuxi, CN
Recent devices under product code PNN
view allData sourced from openFDA. This site is unofficial and independent of the FDA.