AMX Navigate— 510(k) K210982
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K210982 for AMX Navigate, Substantially Equivalent on 2021-04-28. Applicant: Ge Medical Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, LLC
- 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
- Waukesha, WI, US
Recent devices under product code IZL
view allMore clearances from Ge Medical Systems, LLC
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 →
Recalls naming K210982
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210982.
Data sourced from openFDA. This site is unofficial and independent of the FDA.