autoSCORE— 510(k) K231068
Substantially EquivalentHolberg Eeg AS
FDA 510(k) clearance K231068 for autoSCORE, Substantially Equivalent on 2024-01-07. Applicant: Holberg Eeg AS. Device class: 2.
Clearance details
- Applicant
- Holberg Eeg AS
- Product code
- Code OMB
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bergen, NO
Recent devices under product code OMB
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