Atalante X— 510(k) K232077

Substantially Equivalent

Wandercraft SAS

FDA 510(k) clearance K232077 for Atalante X, Substantially Equivalent on 2023-12-13. Applicant: Wandercraft SAS. Device class: 2.

Clearance details

Applicant: Wandercraft SAS
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2023-07-13
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHL

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K233695 — Medical HAL Lower Limb Type (HAL-ML)2024-05-07

More clearances from Wandercraft SAS

K221859 — Atalante2022-12-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.