GALILEO NT— 510(k) K142064
Substantially EquivalentEb Neuro S.P.A.
FDA 510(k) clearance K142064 for GALILEO NT, Substantially Equivalent on 2015-02-13. Applicant: Eb Neuro S.P.A.. Device class: 2.
Clearance details
- Applicant
- Eb Neuro S.P.A.
- Product code
- Code OLT
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianpolis, IN, US
Recent devices under product code OLT
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view allAdverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
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.