Okti— 510(k) K230073
Substantially EquivalentCompumedics Limited
FDA 510(k) clearance K230073 for Okti, Substantially Equivalent on 2023-02-09. Applicant: Compumedics Limited. Device class: 2.
Clearance details
- Applicant
- Compumedics Limited
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbotsford, AU
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