GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM— 510(k) K073408
Substantially EquivalentGe Medical Systems Ultrasound and Primary Care Dia
FDA 510(k) clearance K073408 for GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM, Substantially Equivalent on 2007-12-19. Applicant: Ge Medical Systems Ultrasound and Primary Care Dia. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Ultrasound and Primary Care Dia
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wauwatosa, WI, US
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More clearances from Ge Medical Systems Ultrasound and Primary Care Dia
view allAdverse 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.