MYLAB30, MODEL 7300— 510(k) K071996
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K071996 for MYLAB30, MODEL 7300, Substantially Equivalent on 2007-08-03. Applicant: Esaote, S.p.A.. Device class: 2.
Clearance details
- Applicant
- Esaote, S.p.A.
- 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
- Carmel, IN, US
Recent devices under product code IYO
view allMore clearances from Esaote, S.p.A.
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.