SANDMAN ELITE— 510(k) K153353
Substantially EquivalentEmbla Systems
FDA 510(k) clearance K153353 for SANDMAN ELITE, Substantially Equivalent on 2016-06-23. Applicant: Embla Systems. Device class: 2.
Clearance details
- Applicant
- Embla Systems
- Product code
- Code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kanata, CA
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