V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER— 510(k) K052021
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K052021 for V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER, Substantially Equivalent on 2005-08-17. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code ITX
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.