GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X— 510(k) K032656
Substantially EquivalentGe Med. Systems Ultrasound & Prim. Care Diag.,Llc
FDA 510(k) clearance K032656 for GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X, Substantially Equivalent on 2003-10-30. Applicant: Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc.
Clearance details
- Applicant
- Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, US
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.