MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150— 510(k) K052805
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K052805 for MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150, Substantially Equivalent on 2005-10-17. 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
- Indianpolis, IN, US
Recent devices under product code IYN
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- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
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.