GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85— 510(k) K180543
Substantially EquivalentSamsung Electronics Co., Ltd.
FDA 510(k) clearance K180543 for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85, Substantially Equivalent on 2018-05-24. Applicant: Samsung Electronics Co., Ltd..
Clearance details
- Applicant
- Samsung Electronics Co., Ltd.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon-Si, 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.