GE DEFINIUM AMX 700, MODEL AMX 700— 510(k) K052897
Substantially EquivalentGeneral Electric Medical Systems
FDA 510(k) clearance K052897 for GE DEFINIUM AMX 700, MODEL AMX 700, Substantially Equivalent on 2005-11-08. Applicant: General Electric Medical Systems. Device class: 2.
Clearance details
- Applicant
- General Electric Medical Systems
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, US
Recent devices under product code IZL
view allMore clearances from General Electric Medical Systems
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.