6430 MyLabX75, 6430 MyLab XPro75— 510(k) K212021
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K212021 for 6430 MyLabX75, 6430 MyLab XPro75, Substantially Equivalent on 2021-09-16. Applicant: Esaote, S.p.A.. Device class: 2.
Clearance details
- Applicant
- Esaote, S.p.A.
- 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
- Traditional
- Location
- Genoa, IT
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More clearances from Esaote, S.p.A.
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.