DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D— 510(k) K083640
Substantially EquivalentChoong Wae Medical Corp.
FDA 510(k) clearance K083640 for DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D, Substantially Equivalent on 2009-06-29. Applicant: Choong Wae Medical Corp..
Clearance details
- Applicant
- Choong Wae Medical Corp.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Echo, OR, US
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.