GE OEC ALTITUDE— 510(k) K052039
Substantially EquivalentGe Oec Medical Systems
FDA 510(k) clearance K052039 for GE OEC ALTITUDE, Substantially Equivalent on 2005-08-11. Applicant: Ge Oec Medical Systems. Device class: 2.
Clearance details
- Applicant
- Ge Oec Medical Systems
- Product code
- Code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Salt Lake City, UT, US
Recent devices under product code IZI
view allMore clearances from Ge Oec Medical Systems
view allAdverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.