VIVID 7 WITH SONOPAC, MODEL FB0008XX— 510(k) K003931
Substantially EquivalentGe Medical Systems, Inc.
FDA 510(k) clearance K003931 for VIVID 7 WITH SONOPAC, MODEL FB0008XX, Substantially Equivalent on 2001-01-18. Applicant: Ge Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, Inc.
- 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
- Milwaukee, WI, US
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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.