Okti— 510(k) K230073

Substantially Equivalent

Compumedics 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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