SANDMAN POCKET— 510(k) K061996
Substantially EquivalentEb Neuro S.P.A.
FDA 510(k) clearance K061996 for SANDMAN POCKET, Substantially Equivalent on 2006-10-03. Applicant: Eb Neuro S.P.A.. Device class: 2.
Clearance details
- Applicant
- Eb Neuro S.P.A.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carmel, IN, US
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