Knee+— 510(k) K230789

Substantially Equivalent

Pixee Medical

FDA 510(k) clearance K230789 for Knee+, Substantially Equivalent on 2023-04-21. Applicant: Pixee Medical. Device class: 2.

Clearance details

Applicant: Pixee Medical
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2023-03-22
Decision date: 2023-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Besancon, FR

Download summary PDF View on FDA.gov ↗

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