CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM— 510(k) K101779
Substantially EquivalentJpi Healthcare Co, Ltd.
FDA 510(k) clearance K101779 for CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM, Substantially Equivalent on 2011-05-16. Applicant: Jpi Healthcare Co, Ltd..
Clearance details
- Applicant
- Jpi Healthcare Co, Ltd.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.