Keeogo Dermoskeleton System— 510(k) K201539

Substantially Equivalent

B-Temia, Inc.

FDA 510(k) clearance K201539 for Keeogo Dermoskeleton System, Substantially Equivalent on 2020-09-09. Applicant: B-Temia, Inc.. Device class: 2.

Clearance details

Applicant: B-Temia, Inc.
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2020-06-09
Decision date: 2020-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St-Augustin-De-Desmaures, CA

Download summary PDF View on FDA.gov ↗

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