EnsoSleep— 510(k) K210034
Substantially EquivalentEnsodata, Inc.
FDA 510(k) clearance K210034 for EnsoSleep, Substantially Equivalent on 2021-06-16. Applicant: Ensodata, Inc.. Device class: 2.
Clearance details
- Applicant
- Ensodata, Inc.
- 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
- Madison, WI, US
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