MIZAR, BASIS BE, SANDMAN DIGITAL— 510(k) K003154
Substantially EquivalentEb Neuro S.P.A.
FDA 510(k) clearance K003154 for MIZAR, BASIS BE, SANDMAN DIGITAL, Substantially Equivalent on 2001-01-05. Applicant: Eb Neuro S.P.A.. Device class: 2.
Clearance details
- Applicant
- Eb Neuro S.P.A.
- Product code
- Code GWL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1835
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianpolis, IN, US
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