MOBILETTE XP AND MOBILETT XPHYBRID— 510(k) K033238
Substantially EquivalentSiemens Medical Systems, Inc.
FDA 510(k) clearance K033238 for MOBILETTE XP AND MOBILETT XPHYBRID, Substantially Equivalent on 2003-11-14. Applicant: Siemens Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Systems, Inc.
- 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
- Mavern, PA, US
Recent devices under product code IZL
view allMore clearances from Siemens Medical Systems, Inc.
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 K033238
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 K033238.
Data sourced from openFDA. This site is unofficial and independent of the FDA.