SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K981626
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K981626 for SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 1998-05-27. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Issaquah, WA, US
Recent devices under product code IYO
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.